Towards an effective mechanism for improving coordination ...€¦ · 2 INTRODUCTION AND CONTEXT 2.1 BACKGROUND PAPER: CONTEXT This background paper is prepared in furtherance of

Towards an effective mechanism for improving coordination of investments in clinicalresearch,andresearchcapacitystrengtheninginlowandmiddle-incomecountries(LMICs)

ConsultationBackgroundPaper

PreparedfortheESSENCEWorkingGroupforthedevelopmentofamechanismforreviewing

investmentsinclinicalresearchcapacitybuildinginLMICs(WGRI)

Note:Thispaperwaspreparedasinputtoongoingconsultationsaimedatachievinggreatereffectiveness

incoordinating researchcapacitystrengthening investments inLMICs.Thecontentof thisdocument is

based on literature reviews and key informant interviewswhich though extensive,were by nomeans

exhaustive,andonlyrepresentapartofthebroadconsultationsrequiredformeaningfulandactionable

recommendationsonthissubjecttobemade,orfinaldecisionsreached.Thepaperdoesnotrepresentthe

finaloutputoftheworkinggroup.

1 CONTENTSExecutiveSummary......................................................................................................................................4

2 IntroductionandContext.....................................................................................................................6

2.1 BackgroundPaper:ContextandApproach..................................................................................6

2.2 DefinitionofKeyTerms................................................................................................................7

2.3 Examiningtherationale:gapsandbarrierslimitingeffectivecoordination................................8

2.4 Keyconsiderationsfortheenvisagedmechanism:scope&userneeds....................................12

2.4.1 Scopeconsiderationsforaneffectivemechanism.............................................................12

2.4.2 Analysisofuserneedsandrequirements..........................................................................13

3 LandscapeofClinicalResearchCapacity&ResearchCapacityStrengtheninginLMICs....................16

3.1 Overview....................................................................................................................................16

3.2 AssessingClinicalResearchCapacity/CapacityStrengthening:CurrentLandscape...................16

3.2.1 AssessingandIndicatingClinicalResearchCapacity..........................................................16

3.2.2 AssessingClinicalResearchCapacityStrengtheningInvestments......................................18

3.3 Inventory/reviewofexistingmechanismsforimprovingcoordination.....................................22

3.4 Synthesisofkeyfindingsonthelandscapereview....................................................................25

4 Coordinationmechanisms:alternativemodelsandoptionstoconsider...........................................28

4.1 Overview....................................................................................................................................28

4.2 Casestudies:models&mechanismsforimprovingcoordination.............................................28

4.2.1 CaseStudy#1:TheCGIARPlatformforBigDatainAgriculture.........................................28

4.2.2 CaseStudy#2:TheUNOfficeoftheCoordinationofHumanitarianAffairs(UN:OCHA)..30

4.2.3 CaseStudy#3:Vivli–TheCenterforGlobalClinicalResearchData..................................33

4.2.4 Comparingthethreemodelsreflectedinthecasestudies................................................34

5 Recommendingamoreeffectivemechanism:Guidingprinciplesandstrategicframework.............36

5.1 OverviewandGuidingPrinciples................................................................................................36

5.2 ProposedFrameworkforConsideringOptions&Alternatives..................................................37

6 Bibliography/References....................................................................................................................40

7 Appendix............................................................................................................................................42

7.1 KeyInformantInterviews...........................................................................................................42

7.2 Definition/characterizationofRC&RCS....................................................................................44

7.3 SummaryofIVTFRecommendations.........................................................................................45

7.4 Highlevelprofilesofselectedrelevantmechanisms.................................................................47

7.5 Approachtodevelopingthebackgroundpaper.........................................................................61

7.6 Metricsforassessingnationalbiomedicalresearchcapacity....................................................62

ListofTables

Table1-Analysisofuserneedsandrequirements....................................................................................14

Table2–Identifiedtoolsforassessingandindicatingcapacitylevelsforelementsofhealth/clinicalresearch......................................................................................................................................................17

Table3-Platformswithdatarelevanttoclinical/healthresearchcapacitystrengtheninginLMICs.........21

Table4-Existingmechanismsandtheirkeyattributes.............................................................................24

Table5-Keyattributesofeachmodel.......................................................................................................34

Table6-Illustrativeframeworkfortheconsiderationofalternatives.......................................................39

Table7:Investmentinresearchcapacitystrengtheningbytypeandlevelofcapacity.............................42

Table7:Investmentinresearchcapacitystrengtheningbytypeandlevelofcapacity.............................44

ListofFigures

Figure1-OCHAHumanitarianProgrammeLifecycle.................................................................................31

Figure2-HowtheFTSWorks....................................................................................................................32

Figure3-VivliPlatformProcess..................................................................................................................33

Figure4-Frameworktoguideuseofthebackgroundpaperforpreparation..........................................37

Figure5-Deliberation/outputworksheet(proposal,subjecttomodification)..........................................38

EXECUTIVESUMMARY

Context

This background paper is prepared in furtherance of Recommendation 12 of the Task Force onStrengtheningCountryCapacityforVaccinesResearchandDevelopment(IVTF),convenedbytheWorldBank(WB)andtheCoalitionforEpidemicPreparednessandInnovation(CEPI)inOctober2017todevelopasetofrecommendationsonstrategicinvestmentsthatcanstrengthenclinicalresearchandclinicaltrialcapacity in low- and middle-income countries (LMICs). Recommendation 12 requires, ESSENCE, incollaborationwiththeGlobalCoordinationMechanismtoarticulateamechanismthatpermitsathoroughreviewofcurrentandplanned investments inresearchcapacitystrengthening inLMICs,bytheendof2019. This mechanism is expected to ensure synergy at country and regional levels, with respect toinvestmentsinresearchcapacitystrengtheninginthesecountries.

Thepurposeof thispaper is toenableparticipants in theMarch2019consultative session,efficientlyarriveatacommonpositiononthewhy,whatandhowoftheenvisagedmechanism,toinformactionablerecommendations.

Theprimarythesisofthispaperisthatgreatersynergyandenhancedcoordinationbetweenandamongstfundersofhealthresearch,researchorganisations,usersofclinicalresearch,andotherkeyactorsinLMICscanbe achieved through an effectivemechanism, that improvesmulti-stakeholder engagement, andprovidesacommonsetofprinciples,metrics,dataandstandardstobetterinforminvestmentdecisionsonclinicalresearchcapacitybuildingandstrengthening.

Barrierstosurmount

Based on literature reviews and expert interviews, the paper highlights two critical problems, whichcurrentlymilitate against effective coordination of clinical/health research investments - (a) inherentdifficultiesinsettingandagreeingoncapacitystrengtheningprioritiesforLMICsduetolackofqualitydataonwhathealthresearchandcapacitystrengtheningprogramsisbeingconductedorplanned,andlackofinformationonthecurrentcapacityatnationalandinstitutionallevel;(b)complexitiesintheinstitutionallandscapeforhealthR&Dwhichlimiteffectivecollaborationwithinandamongmultipleinstitutions.Theinherent complexities are also apparent in the diversity of needs and requirements by differentstakeholdergroups.

Keyelementsofthecurrentlandscapeandimplicationsforthemechanism

ThepaperundertakesanextensivereviewofthecurrentlandscapeforassessingclinicalresearchcapacityandinvestinginclinicalresearchcapacitystrengtheninginLMICs.Basedonthisreview,ithighlightsforconsideration,threedefiningelementswhichshouldinfluencethedesignofamoreeffectivemechanism:

1. Absence of strong nationally-owned systems for assessing/evaluating clinical/health research

capacityandsharingtheresultsofsuchassessments;

2. Useofmultiple,discreteexternallydesignedsystemstoassessclinical/healthresearchcapacity

and/orreviewresearchcapacitystrengtheninginvestmentsinLMICswithoutenoughalignment

inobjectivesanddatasetsusedtoinformsuchassessments/reviews;and

3. Absenceoforganizations/entitiesthathaveabroadenoughremittolead/driveaholisticapproach

to coordination, yet structurally and functionally simple enough to navigate the institutional

complexitiesinherentinthelandscape

Theimplicationofthesedefiningelementsofthelandscapeisthattodesignamoreeffectivemechanism,participantsattheconsultationwillneedto:

1. Considerwaystoimprovethedefinitionofcompetenciesandstandardsthatreflectcapacity,andways to encourage usage and uptake of assessment frameworks by LMICs, to increase theavailability of quality country-generated data on prevailing capacity and simplify gapanalysis/interventiondesign.

2. Figureouthowtoaddresstheinstitutionalcomplexityissue,giventhatdata-sharingsystemsthataredesigned tomeet theneedsof all stakeholders run the risk of being either too simple tosatisfactorilyaddresstheseneedsorbecomingtoocomplextobeefficientlyandcost-effectivelymaintainedandkeptrelevant.Findingtheright-subsetofstakeholderneedsthatcanbemettocreatethemostimpactandtherightsubsetofdatatooptimizeandmakemoremeaningfulshouldbeconsideredindepth.Soisdesigningtherightformatforthepresentationofdatatomaximizeitsutility.

3. Decide on the appropriate organizational entity within which this mechanism should beembeddedandresolveimportantquestionsofhowitisgovernedandfundedwithoutnegativelyimpacting its LMIC focus, organizational agility and responsiveness, and neutrality. Achievingcollectiveaccountabilityamongstparticipatingorganisationsinawaythatisnon-threateningyeteffective,shouldbeapriority.

Designingthemechanism/makingrecommendations

Effectivedeliberationstorecommendabettermechanismwillrequirestakeholderalignmentaroundthedesiredendstatethatthemechanismisexpectedtobringabout,agreementonasetofguidingprinciples,andaclearframeworkforthinkingabouthowtostructuretherecommendationstorealizetheenvisagedmechanism.Tosupportthis,thispaperpresentsafewpotentiallyusefulcasestudies(mainlyoutsidethehealth research ecosystem) to enrich the ideation process, and in the final section, proposes somelanguageonthedesiredend-state,suggestsafewguidingprinciples,andthenlaysoutaframeworktoguidethecollectiveprocessofdevelopingrecommendationsattheMarch2019consultationsession.

2 INTRODUCTIONANDCONTEXT

2.1 BACKGROUNDPAPER:CONTEXT

This background paper is prepared in furtherance of Recommendation 121 of the Task Force on

StrengtheningCountryCapacityforVaccinesResearchandDevelopment(IVTF),convenedbytheWorldBank(WB)andtheCoalitionforEpidemicPreparednessandInnovation(CEPI)inOctober2017todevelopasetofrecommendationsonstrategicinvestmentsthatcanstrengthenclinicalresearchandclinicaltrialcapacityinLMICs2.Itispreparedtoinformanupcomingmulti-stakeholderconsultativesession(scheduledfor early March 2019) convened by the ESSENCE for Health Research Working Group 3 , aimed atarticulatinganeffectivemechanismthatpermitsathoroughreviewofcurrentandplannedinvestmentsinclinicalresearchcapacitystrengtheninginLMICs,tomakeglobalcoordinationmoreeffective.

Theprimarythesisofthispaperisthatgreatersynergyandenhancedcoordinationbetweenandamongstfundersofhealthresearch,researchorganisations,usersofclinicalresearch,andotherkeyactorsinLMICscanbeachievedthroughaneffectivemechanism, that improvesmulti-stakeholderengagement,andprovidesacommonsetofprinciples,metrics,dataandstandardstobetterinforminvestmentdecisionson clinical research capacity building and strengthening. To enable participants in the March 2019consultativesession,arriveatacommonpositiononhowtheabovecanberealized,thispaperprovidessynthesizeddataon the landscapeofclinical researchcapacityandresearchcapacitystrengthening inLMICs, with respect to coordination of research investments in LMICs through various existingmechanisms.Basedonthislandscapereview,thepaperhighlightskeyissuesandexistinggaps,thatshouldinformeffectivedeliberationonwhataneffective,sustainablemechanismcouldlooklike.ThepaperalsosuggestsafewstrategicalternativesforconsiderationinthedesignofaneffectivemechanismforgreatercoordinationofclinicalresearchcapacitystrengtheninginvestmentsinLMICs.

1SeeAppendixforthefullsetofrecommendationsinthereport.Readthefullreporthere:http://documents.worldbank.org/curated/en/120551526675250202/pdf/126338-REVISED-27231-IVTF-Report-reduced.pdf2Thereportofthetaskforce,titledMoneyandMicrobes:StrengtheningResearchCapacitytoPreventEpidemics,waslaunchedattheWorldHealthAssembly,May20183ESSENCEforHealthResearchWorkingGroupforthedevelopmentofamechanismforreviewinginvestmentsinclinicalresearchcapacitybuildinginLMICs(WGRI)wasconvenedinOctober2017todrivetheimplementationofRecommendation#12

Recommendation12:Byend2019,ESSENCE,incollaborationwiththeGlobalCoordinationMechanismandreinforcedwithadditionalLMICrepresentation,shouldarticulatea

mechanismthatpermitsathoroughreviewofcurrentandplannedinvestmentsinresearchcapacitystrengthening.Thisshouldbedoneinconsultationwithmajorexternalfundersofclinicalresearch(includingthoseinvolvedincapacitystrengtheningofnetwork,laboratory,ethics,andregulatorycapability).Thiscollaborativemechanismshouldensuresynergyatcountryandregionallevels,andstreamlinetheadministrativeburdenexperiencedby

institutionsdealingwithmultipleresearchfunders.

Thepaperfollowsananalyticalapproachtoprovidingtheevidenceneededtoinformdeliberationsattheconsultativesessionbyseekingtoaddressthefollowingkeyquestionsinsequence:

1. Whydoestheworldneedthismechanism?WhatarethemajorgapsorbarriersaffectingeffectivecoordinationofinvestmentsinclinicalresearchcapacitystrengtheninginLMICsthatitseekstoaddress?

2. Whatcouldaneffectivemechanismlooklike?Howshoulditbeenvisioned?a. Whowouldbethemainusers?Whataretheirneedsandhowwilltheybenefit?b. What should be the ideal scope? What are the key actions envisaged and related

components?3. What is the landscape of assessing clinical research capacity and clinical research capacity

strengthening in LMICs presently? What are the implications for designing an effectivemechanism?

4. WhataretheexistingmechanismsforcoordinatingclinicalresearchinvestmentsintoLMICsandwhatistheirscope?Whatarethekeyissuesandgapslimitingtheireffectivenessincoordinatinginvestments?

5. Whatmodelsforinvestmentcoordination/reviewmechanismsfromwithinoroutsidethehealthresearch ecosystem canwe learn from tomake effective recommendations on the envisagedmechanism?

2.2 DEFINITIONOFKEYTERMS

1. Clinical Research: Clinical research is a component of medical and health research intended toproduceknowledgevaluableforunderstandinghumandisease,preventingandtreatingillness,andpromoting health. Clinical Research embraces a continuumof studies involving interactionswithpatients,diagnosticclinicalmaterialsordata,orpopulations.4

2. Clinical Research Capacity: Though narrow in scope by theoretical definition, this paper definesclinical research capacity holistically as part of the big picture of capacity for health research ingeneral,whichisnowwidelyacknowledgedasthelinchpinofeffectiveandefficienthealthsystems.Emphasis is on capacity for sustainable clinical research, and the required fundamentals such asinfrastructure,education,legalandregulatoryframework,andtheabilitytoconductclinicalresearchduringoutbreaks.Accordingly,referencestoclinicalresearchcapacityinthispaperlieonaspectrumbetweenanarrowfocusonclinicalandbehavioralresearchandmorebroadlyothercriticalaspectsofhealthresearchincludingbiomedicalresearch,populationhealthresearch,andsomeaspectsofhealthpolicyandsystemsresearch.

3. Research Capacity Strengthening: This has been formally defined as “any effort to increase theabilityofindividualsandinstitutionstoundertakehigh-qualityresearchandtoengagewiththewidercommunityofstakeholders”5.Forthepurposesofthispaper,thedefinitionisbroadenedtoinclude

4ClinicalResearch:ANationalCalltoAction,November1999,USNationalInstitutesofHealth5Sevenprinciplesforstrengtheningresearchcapacityinlow-andmiddle-incomecountries:simpleideasinacomplexworld;ESSENCEGoodPracticeDocument

‘capacitybuilding’which is typicallydistinguished from ‘capacity strengthening’by itsuseonly incontextswherecapacityisorwasnon-existent.

2.3 EXAMININGTHERATIONALE:GAPSANDBARRIERSLIMITINGEFFECTIVECOORDINATION

Within the last two decades, concerted efforts have been directed towards finding effectiveways toactualizeclinicalresearchcapacitystrengtheningtoimprovetheperformanceofnationalhealthresearchsystemsinlow-andmiddle-incomecountries(LMICs).Asignificantproportionoftheseeffortshaveandcontinuetogointotrainingandsupportingindividualinvestigators,enhancingthecapacityofresearchinstitutions, strengthening health research leadership and regulatory capacity at national level, andimprovingtheefficacyofcollaborativeresearchacrossthesecountries.Adiversesetofactorshavebeeninvolvedwithfundingandresourcingtheseefforts.Theseincludekeyorganizationsconductingresearch,pharmaceuticalandbiotechnologycompanies,academicinstitutesanduniversities,productdevelopmentpartnerships, research focused foundations/charitable organisations, and governmental developmentagencies.Thesheerdiversityinthenumberofactors,andthefactthatmanyactorsplayacrossmultiplerolesmakestheglobalinstitutionallandscapeforhealthresearchparticularlycomplex.

Giventhiscomplexity,risingglobalinterestinincreasingthequantumoffinancingforclinicalresearchinLMICshasbeenaccompaniedbycallsforbettercoordinationofhealthresearchrelevanttodevelopingcountries,toensurethatscarcefundsarebeingefficientlyallocated.Thedemandforbettercoordinationhasalsobeendrivenbytheneedtoavoidwastefulduplicationofefforts,withseveralgroups‘addressingthe sameobjectiveor following the same researchpaths in isolation fromeachother’6, limiting theiroverall impactonLMICnationalhealth research systems.Theprimarypurposeof coordination in thiscontexthasbeentoensurethat‘newdrugs,vaccinesanddiagnosticsneededtotreatdiseasesthatareprevalent in low- andmiddle-income countries are developed and are safe, effective, affordable andsuitablefortheconditionsinwhichtheywillbeused,therebycontributingtobetterhealthandhealthequity globally’7. Critically important here is the need to ensure that aminimum level of capacity isavailableacrossallcountriessuchthat“holesinthemap”areavoided,andweaknessesinonecountrydonot unduly expose regional health systems to greater risk. Secondary objectives include avoidingunnecessaryduplicationofeffortandwastedfunding,ensuringthaturgentorneglectedareasbecomepriorities,byassistingpolicy-makersanddonorsinsettingandmanagingtheirpriorities;facilitatingbettercooperationbetween thepublic andprivate sectors; andpromoting the inclusionof awider rangeofactors,suchasbyensuringtheinvolvementofresearchersinlow-andmiddle-incomecountriesinfindingsolutionstoproblemsassessedasrelevantforthemaspartofresearchcapacitystrengtheninginthosecountries8.

Highlevelchronologyofeffortstobettercoordinateclinical/healthRCSinLMICs

Successivecommissionsandconferencesonhealthresearchhavemaderecommendationsonimprovingcoordination and taken necessary actions. This section outlines in brief how some of theserecommendationsandactionshaveevolved/influencedthepresentlandscape.6ResearchandDevelopmenttoMeetHealthNeedsinDevelopingCountries:StrengtheningGlobalFinancingandCoordination;ReportoftheConsultativeExpertWorkingGrouponResearchandDevelopment:FinancingandCoordination;2012;WorldHealthOrganization7ResearchandDevelopmentCoordination&Financing:ReportoftheExpertWorkingGroup;2010;WorldHealthOrganization8Ibid6

§ The Commission on Health Research for Development (CHRD) recognized the need for “…a

mechanism tomonitor the progress of research on developing-country needs and to identifyunmet needs…”9which led to the emergence in 1993 of the Council onHealth Research andDevelopment(COHRED)asasupportmechanismforcountriesinareassuchashealthresearchsystem assessment and development, policy development, priority-setting and researchcommunication.

§ TheAdHocCommitteeonHealthResearchRelatingtoFutureInterventionOptionsin1996madea similar recommendation10, leading to the creationof theGlobal Forum forHealthResearch(GFHR)in1998.TheGFHRwasmergedwithCOHREDin2010.11

§ TDR,theSpecialProgramforResearchandTraininginTropicalDiseases,establishedmorethan40yearsagoisinitselfaglobalprogramofscientificcollaborationthathelpsfacilitate,supportandinfluenceeffortstocombatdiseasesofpoverty.ItishostedattheWorldHealthOrganization(WHO) and is sponsored by theUnitedNations Children’s Fund (UNICEF), theUnitedNationsDevelopment Program (UNDP), the World Bank and WHO. TDR is currently funded throughfinancial core contributions by National Agencies from 15 countries, plusWHO as well as byspecific project funding from 3 other organizations. Aswell as being a collaboration ofmanyStates,TDRisinvolvedinseveralinitiativeswhichrelatetocoordinationand/orcapacity-building,includingtheAfricanNetworkforDrugsandDiagnosticsInnovation(ANDI),andtheInitiativetoStrengthenHealthResearchCapacityinAfrica(ISHReCA)12.

§ ESSENCE(EnhancingSupportforStrengtheningtheEffectivenessofNationalCapacityEfforts)onhealthresearchinitiativewasestablishedfollowingameetingin2008inStockholmattendedbya number of funding organizations. The initial executive groupwasmade up of the followingorganizations: the United Kingdom Department for International Development (DFID),International Development Research Centre (IDRC), the Ministry of Foreign Affairs of theNetherlands, Norwegian, Agency for Development Cooperation (Norad), the SwedishInternationalDevelopmentCooperationAgency(Sida)–plustheBill&MelindaGatesFoundationandtheWellcomeTrust.TDRwasrequestedtoactasthesecretariatforESSENCE.

§ Further evidence of collective action and investment to improve coordination include theWHO/WorldBank/UNSpecialProgrammeofResearch,DevelopmentandResearchTraining inHumanReproduction (HPR); the InternationalClinical TrialsRegistryPlatform (ICTRP)which isaimed at increasing the availability of structured information on clinical trials; and theGlobalCoordinationMechanismoftheR&DBlueprint(GCM)launchedin201713

9Ibid610Ibid611AWorldBankevaluationin2009noted:“...butitisnotclearthattheGFHRhassubstantiallyinfluencedthelevelandallocationoftotalglobalhealthresearchexpenditure.ItscoreadvocacyexpendituresofUS$3.5millionayearcouldhardlybeexpectedtohaveasubstantialimpactonthelevelandallocationofthecurrentworldtotalofUS$160billioninannualspendingonhealthresearch...TheForumdoesnotappeartohavehadasignificantimpactonresearchprioritysettingwithingivenallocations.Thisisespeciallythecaseatthegloballevelwhichisthecoreofitsmission.”Ibid612ReviewbytheConsultativeExpertWorkingGrouponFinancing&CoordinationforHealthR&DofinitiativesoftheWHOaimedatimprovingcoordinationnotedthatwhilsttheyhavebeenusefultovaryingdegrees,they“haveoverlappingobjectivesbutseparategovernancearrangements”,arguingthatthereisscopeforrationalization.13MeetingSummaryNotes:EstablishingaGlobalCoordinationMechanismofR&Dtopreventandrespondtoepidemics–TowardimplementationoftheGCM;https://www.who.int/blueprint/what/improving-coordination/GCM2017_meetingsummary.pdf?ua=1

§ Severalothereffortsatimprovingcoordinationhavebeendrivenbyorganisationsoutsideofthe

WHO,mostactorsworkingeitherinisolation,oraspartofsmallcollaborativegroupsofsub-setsoforganizationswithsharedgoals.TheseincludebutarenotlimitedtotheProductDevelopmentPartnerships(PDP)FundersForum,theHeadsofInternationalResearchOrganizations(HIROS),theInternationalForumofResearchDonors(IFORD).

§ The European and Developing Countries Clinical Trials Partnership (EDCTP) is a collaborationbetween European Union States and African States. The collaborative program funds clinicalresearch to acceleratethe development of new or improved interventions against severalpoverty-relatedinfectiousdiseasesinsub-SaharanAfrica,withafocusonphaseIIandIIIclinicaltrials.TheinitiativereceivesfundsfromtheEuropeanCommissiontobematchedbyEuropean&MemberStates.

Summaryofkeybarrierstobettercoordinationofclinical/healthRCSinLMICs

Whilethereisacknowledgementwithinthescientificresearchcommunitythatsomeprogresshasbeenmadeinimprovingcoordinationofclinicalresearchcapacityoverthepasttwodecades,thereisalsoanadmission that several of the problems that necessitated the early efforts aimed at improvingcoordinationarestillpresent.Someofthecriticalbarriersmentionedinliteratureareoutlinedbelow:

1. Inherent difficulties in setting and agreeing on capacity strengthening priorities – Currently,thereisnosystemtosystematicallyandperiodicallymapwhathealthresearchisneededinLMICsvis-à-viscurrentcapacityofLMICcountriesanddetailtheimplicationsforcapacitystrengthening.Although ‘substantial progress has been made in evaluating the burdens of existing healthproblems,theneedfornewknowledgeandproductsisonlyassessedonanad-hocbasisandforaselectednumberofdiseases’14.ThereisalsonosystemtofacilitatetheprioritizationofLMIChealthresearchneedsandagreestrategicfocusareas.Theabilitytomapneeds,identifycapacitygaps,andimplicationsforcapacitystrengthening,anddetermineprioritiesiscurrentlylimitedforthefollowingreasons:

a. Dataavailabilityandutility:Limitedeffectivedata sharingonwhathealth research isbeingconducted,andwhatcapacitystrengtheningprogramsor initiativesareongoing.There is a dearth of data on what investments in research/research capacitystrengthening are already planned, which limits the predictive value, and utility, ofexistingdatasets.Theabsenceofforward-lookingdataispartlysystemic,becauselargefundersofscientificresearchandresearchorganizationsadoptacompetitiveapproachtoallocating research investments,hence theirportfoliosare shapedby the sourceofsuccessful proposals, as against pre-defined priority disease areas or target countries.Theseextantorganisationalnormsconflictwith traditional ‘internationaldevelopment

14“Themismatchbetweenthehealthresearchanddevelopment(R&D)thatisneededandtheR&Dthatisundertaken:anoverviewoftheproblem,thecauses,andsolutions”;RoderikF.Viergever(2013)

organizations’whofundresearch inLMICsandhaveportfolioshapedbyapre-definedagenda,withimplicationsforutilityandavailabilityofdata.

b. Data consistency and integrity: The absence of an effective clinical research datamanagement arrangement that enables clinical research capacity considerations forLMICstobeinformedbyaconsistentsetofdata.Useofdisparatedatasetsbydifferentactors creates a degree of information asymmetry that mitigates against reachingharmonious,forward-lookingdecisionsonresearchcapacityinvestments.

c. Capacityassessmentpractices:Theabsenceofawidelyadopted,standardsystemforassessing/measuring clinical research capacity, especially at the institutional andcountry/national level. In the absence of common metrics and indices, stakeholdersadoptproxymeasures,leadingtoinaccuratesignalingofprevailingcapacitylevels,andpoorarticulationofcapacitygaps.Thisissuehasbeenwidelyacknowledged,andisthesubject of Recommendation 5

15

of the aforementioned IVTF Task Force report, yetconcreteactiontoimprovethisisyettogathertraction.

2. Inherentcomplexitiesintheinstitutionalenvironment:Asthere’scurrentlynotrulyrecognized

globalcoordinationmechanismforhealthresearchcapacitystrengthening,there’scurrentlyanunderstandingthatallactorsare“jointlyresponsible”forensuringthatcoordinationoccursandiseffective16.Thediversityofthelandscapeandthekeyinstitutions,however,makesthis ideaimpractical.Reasonsinclude:

a. Differing remits and multiple points of accountability: For example, National publicfundersofhealthR&Dhaveoftenbeenestablishedundernationallaws,havenationallyfocusedremits,andareaccountabletotheparliamentoftheirhomecountries,andhencearenotusuallyabletoinvestinresearch/researchcapacitybuildingthatarenottightlylinked to their national and/or political interests. International developmentorganisations that spend Official Development Assistance (ODA) on health R&D haverestrictions that impacthow they spend, asdomultilaterals, including remits that arelimitedtoaspecificsetofdiseases.Thisaffectstheefficacyofattemptsatcoordination,as coordination mechanisms are unable to directly influence tangible and sustainedbehaviorchangeamongstkeyfunders,researchorganisations.

b. Differing organisational and procedural norms: Funders and research organizationscontinue to apply an unwieldy range of research classification systems, makingaggregationofresearchcapacityinvestmentsdifficult.Adoptionanduseofharmonizedprotocols and conventions for documenting clinical research projects, researchattribution,andsyntaxfordescribingspecificelementsofresearchactivityisstillfarfromoptimal.Asistheadoptionofcommonstandardsforthemeasurementofindicatorsof

15“Byend2018,WHOshouldconsolidatearobustsetofindicators,totheextentpossiblebuildingonindicatorsalreadyusedbycountries,developatoolforassessmentofcountry-levelcapacitiesforclinicalresearch,andproposeaprocesstohelpcountriesrapidlyconducttheseassessments.”16TheGlobalMinisterialForumonResearchforHealth(2008)TheBamakocalltoactiononresearchforhealth:strengtheningresearchforhealth,development,andequity;Bamako,Mali.

capacitysuchasqualifiedresearchers,laboratoryquality,ethics,governanceandfinancialmanagement. Differences in other norms such as planning, and budgeting cycles alsoimpacttheprospectofeffectivecoordination.

c. Competitive and/or political dynamics – Many funders (private or public) or health

research are also actively involved in scientific enquiry which introduces a degree ofadditional complexity that is a barrier to effective coordination due to direct or tacitcompetition.Politicaldynamicsbetweeninstitutionsarealsoakeyfactorthatcouldmakeormar attempts at improving coordination. Indeed, anecdotal evidence suggests thatthesedynamicshavebeenthesinglemostimportantfactorthathaverenderedpreviousattemptsataglobalcoordinationmechanismunsuccessful,andexistingmechanismslesseffectivethandesired.

Questionsforparticipants(Section2.3)

§ Are the identified barriers to better coordination in clinical research capacity strengthening

outlinedinthissectionexhaustive?§ Whatothermajorgapsthatnecessitatetheideaofamoreeffectivemechanismaremissing

fromtheabove?

2.4 KEYCONSIDERATIONSFORTHEENVISAGEDMECHANISM:SCOPE&USERNEEDS

Foreffectivemulti-stakeholderdeliberationontheenvisagedmechanism,allparticipantsneedtohaveacommonunderstandingofthekeyconsiderationstobeassessed.Thissectionofthepaperaimstoachievethisbyoutliningasetofassumptionsaboutthemechanismbasedonexistingliteratureonthesubjectand a handful of initial stakeholder interviews. These assumptions are outlined in the following sub-sectionsasanswerstotwodefiningquestion-sets:

1. Whatshouldbetheidealscopeofaneffectivemechanism?Whatarethekeyactionsenvisagedandrelatedcomponents?

2. Whowouldbethemainusersofthismechanism?Whataretheirneedsandhowwilltheybenefitfromitsexistence?

2.4.1 Scopeconsiderationsforaneffectivemechanism

Fromtheprecedingsection,itisevidentthatforamechanismtobeeffectiveinthiscontext,itwillhavetobedesigned toenable/supportmoreeffectivepriority settingwith respect to investing in clinicalresearchcapacitystrengtheninginLMICs,withinthecontextof(andwhilenavigatingtheinherentpitfallsof)acomplexinstitutionallandscape.Thesetwoconsiderationsarethuscriticalindefiningthescopeofthemechanism.

Basedonstakeholderinterviewscompletedtodateinthepreparationofthisbackgroundpaper,thereappears to be a very high level of interest amongst health research ecosystem actors on bettercoordinationof researchcapacitybuilding/strengtheningactivities inLMICs.Whilst there isn’t (now)aclearconsensusonwhatthecomponentsandkeyactionsofthemechanismshouldbe,thefollowingweresuggestedasidealfeaturesofsuchamechanism:

1. Provide a systematicmeans to ensure that capacity strengthening priorities for LMICs areidentified,andthatresearchcapacityinvestmentsarealignedwithcountry/nationalauthorityprioritiesandlinkedtotheiroverallhealthpriorities;

2. Provideaccesstoaccuratedataoncurrentcapacitylevels(withemphasisoninstitutionalandnational level capacity) in LMIC countries, and the implications for capacity strengtheninginvestments,giventheprioritiesestablished;

3. Provide access to accurate data on capacity strengthening programs and interventions inLMICsto informbetterallocationofresourcesbyfunders,andthedesignofmoreeffectivepartnerships;

4. Supportenhanceddirectionofresourcesintoclinicalresearchcapacitystrengthening/building;5. Provide mechanisms to improve accountability amongst stakeholders to ensure that

investmentsinclinicalresearchcapacitybuilding/strengtheningareindeedeffectiveQuestionsforparticipants(Section2.4.1)

§ Arethesuggestedfeaturesofanidealmechanismvalid?§ What is your perspective on the required actions and key components of an effective

mechanism?

2.4.2 Analysisofuserneedsandrequirements

Basedonliteraturereviewsandstakeholderinterviewscompletedaspartofpreparingthispaper,seventypesofstakeholders(inthreebroadcategories)whocollectivelyhaveneedsthataneffectivemechanismforcoordinating investments inclinicalresearchmayhelpaddresswere identified.Thesestakeholderswillbethede-facto‘primaryusers’oftheenvisagedmechanism.Briefdescriptionsofthesestakeholders,alongwithaninitialarticulationoftheirneedsanddesiredbenefitsfromtheenvisagedmechanismareoutlinedinthissection.

Table1-Analysisofuserneedsandrequirements

NB:Theorganization/countrylogosincludedinthetablebelowareillustrativeexamplesonlyandarenotexhaustive

Questionsforparticipants(Section2.4.2)

§ Arethecategoriesofstakeholdersidentifiedinthetableaboveaccurateandexhaustive?§ Whatisyourperspectiveontheneedsofeachstakeholdergroupandhowtheseneedsdifferfromonegrouptothenext?

3 LANDSCAPEOFCLINICALRESEARCHCAPACITY&RESEARCHCAPACITYSTRENGTHENINGINLMICS

3.1 OVERVIEW

InformationprovidedintheprecedingsectionindicatesthatthereiscurrentlynocommonmechanismtoensurethatresearchcapacitystrengtheninginLMICsisoptimizedforgreaterimpact.Thissectionofthepaper goes into further detail to describe the prevailing landscape for clinical research capacity andresearchcapacitystrengtheninginLMICs,byprovidingsecondarydataandsupportinganalysisacrosstwokeyaspectsofthelandscape:

§ Howdataonclinicalresearchcapacityandresearchcapacitystrengtheningiscurrentlyassessed§ ExistingmechanismsforcoordinatingclinicalresearchinvestmentsintoLMICsandtheextentto

whichtheymeetidentifiedneedsoraddressknowngaps

3.2 ASSESSINGCLINICALRESEARCHCAPACITY/CAPACITYSTRENGTHENING:CURRENTLANDSCAPE

3.2.1 AssessingandIndicatingClinicalResearchCapacity

Asearlier indicated, thispaperadoptsadefinitionofclinical researchcapacity thatplaces italongthecontinuumofhealthresearchingeneral,fromanarrowfocusonclinicalresearch,tootherformsofhealthresearchthatarecriticaltoeffectiveandefficienthealthsystems.Theterm‘capacity’inthiscontextistoberegardedas‘amultidimensionalconcept,whichreflectsthecomplexnatureofhumansystemsmadeupofmultipleactorsinteractingwithoneanotherinoftenunpredictableways17.Theobjectiveofcapacitystrengtheningeffortsbeingtoimprovetheabilityofanindividual,organization,sector,orcountrytonotonly produce desirable technical results but also to ‘build more effective and dynamic relationshipsbetweendifferentactorswithinasystem’18inasustainableway.

Thereare currentlynowidely-acceptedmeasuresofassessing capacity for clinical researchat variouslevels,neitherarethereharmonizedratingsofresearchinstitutionsornationalhealthresearchsystemsof low- andmiddle-income countries based on their capacity to undertake clinical research or healthresearch.Afewmechanismsthatdefinecompetenciesand/orbenchmarksforspecificsub-elementsofresearchcapacity,orreportoncapacityassessmentsarehoweverinuse,thoughwithlimitedscopeanduptake.Thetablebelowoutlinesfindingswithrespecttoavailabilityofcurrentlyapplicablemechanismsthatindicate(orseektoindicate)researchcapacityinLMICs.

17Capacity,complexityandconsulting:Lessonsfrommanagingcapacitydevelopmentprojects;2012ODIWorkingpaper18Ibid19

Table2–Identifiedtoolsforassessingandindicatingcapacitylevelsforelementsofhealth/clinicalresearch

Sn Mechanism Level Description

1 TheTDR-TGHNCompetencyWheel19

Individual Providesalistingofrequiredcompetenciesthatshouldbe demonstrated by a research team to carry out asuccessfulclinicalstudy

2 MappingAfricanResearchEthicsReviewandMedicinesRegulatoryCapacity(MARC)20

Institutional/National

MaphealthresearchoversightandregulatoryactivitiesinAfrica, collectingdataonover150African researchethicscommittees

3 TheLaboratoryNetworkScorecard(LABNET)21

National Scorecard used for the assessment of nationallaboratory network functionality in Africa. Limitedevidenceofactualusagethoughitappearstohavebeenwidelypromotedatsomepoint.

4 TheWHOGlobalBenchmarkingToolforRegulatoryCapacity22

National Assesses and documents capacities of nationalregulatory agencies, including the capacity to provideinformedno-objectiontoclinicaltrials,postmarketingsurveillanceandoversightofresearchduringoutbreaks

5 WHOJointExternalEvaluation(JEE)Mechanism23

National Assesses laboratory and surveillancepreparedness forWHO member countries. Voluntary, collaborative,multisectoral process to assess country capacities toprevent, detect and rapidly respond to public healthriskswhetheroccurringnaturallyorduetodeliberateoraccidentalevents.

6 RegulatoryInformationTrackingofClinicalTrialsRegistration&EthicsCommittees(REGTRAC)24

National PartoftheInternationalClinicalTrialPlatform(ICTRP),the REGTRAC database shows what countries havelegislation and regulations on ethics committees andclinical trials registration. Allows the ICTRP to identifythe existing supports and barriers, on a governmentlevel, for the registrationof clinical trials, and in turn,researchtransparency.Currentlypublishingdatafor27countries

7 NationalHealthResearchSystems(NHRS)Dashboard25

National PartoftheGlobalObservatoryforHealthR&D,thisisaquestionnaire-based framework for assessing countrycapacitytogeneratescientificknowledgeandpromoteits utilization to improve health and health equity.Consists of four dimensions of health research -

19TGHN-TheGlobalHealthNetwork20EstablishedbyCOHREDinpartnershipwiththeSouthAfricanResearchEthicsTrainingInitiative21MoreontheLABNETscorecardhttps://au.int/sites/default/files/documents/32386-doc-4._presentation_acdc_labnet_p_ondoa.pdf22MoreonGlobalBenchmarkingToolforregulatoryCapacity-https://www.who.int/medicines/regulation/benchmarking_tool/en/23MoreonWHOJEEMechanismhere-https://www.who.int/ihr/procedures/joint-external-evaluations/en/24MoreonREGTRACherehttp://apps.who.int/trialsearch/regtrac.aspx25PolicypapersupportingthedevelopmentofdatagatheringsystemsfortheNHRS-https://health-policy-systems.biomedcentral.com/articles/10.1186/s12961-015-0054-3

governance, creating and sustaining resources,producingandusingresearch,andfinancing.

8 UNESCOGo-SPIN26andUISStatistics27

Individual/National Provides tools formapping and analyzing national STIlandscape and assessing policies/implementation formorethan50countries;hostsSTIindicatorsforover300countries.UISStatscollectsandreportsoninformationon human resources for scientific research - thisinformation is already accessible through the GlobalObservatoryforHealthR&D.

n Notetoparticipants:Kindlyindicateexistingtoolsandmechanismsliketheabovethatarerelevantto

indicatinginstitutionalornationalcapacityforclinical/healthresearchinLMICsbutarenotlisted.

3.2.2 AssessingClinicalResearchCapacityStrengtheningInvestments

As with clinical research capacity, information on ongoing or planned clinical research capacitystrengthening investments in LMICs is not available in a single integrated source. There are instead,multiplesourcesofdata,availablebasedonexistinginformationsharingcommitmentsbetweenprivateand public funders and research organisations in high income countries (HICs). Most of the data ishowever tightly linkedwith scientific research projects being undertaken in LMICs,making it hard todistinguish investments in scientific research from investments in clinical research capacitybuilding/strengtheninginastrictsense.AsidefromSub-SaharanAfrica,whereinvestmentsindedicatedcapacitystrengtheningeffortshaveincreasedinthepasttwodecades,publiclyavailabledatafromthesesourcesarestoredasactualscientificstudies/trials,andgrantsforvariousformsofresearchactivity,thusprovidinglimitedinsightsintoresearchcapacitystrengtheningefforts inLMICsofSouthAsia,EastAsiaand the Pacific,& LatinAmerican and the Caribbean.Most of the publicly available data is based onpreviousandongoingresearchactivityfundedbylargeglobalfundersofhealthresearchandtheprivatebiomedical industry. Research activities by governments and private actors within LMICs are under-represented in thedominant platforms. Similarly, capacity building/strengthening efforts that are notdirectlylinkedtoscientificresearchactivityareunder-represented.

ThetablebelowoutlinesfindingswithrespecttoplatformsforinferringdataonclinicalresearchcapacitystrengtheninginLMICs.

26Linktosummary-https://en.unesco.org/sites/default/files/gospin_online_platform_leaflet_en.pdf27http://data.uis.unesco.org/

Sn Platform/Host Description Level SourceData

1 TheGlobalObservatoryforHealthR&D(WHO)

Web based portal, backing a global-level initiative that aims to help identify health R&Dprioritiesbasedonpublichealthneeds,byconsolidating,monitoringandanalyzing relevantinformation on the health R&D needs of developing countries; building on existing datacollectionmechanisms;andsupportingcoordinatedactionsonhealthR&D.

Individual,Institutional&National

Multiplesecondarysources;includingtrialregistries

2 WorldReport(NIH) Web based interactive platform managed through a steering committee comprisingorganisations thathaveagreed towork together to improvedata transparencyon researchinvestments.Currentlyincludesdatareportedby12majorfundersofhealthresearch.Notallofthesefundersreportonayearlybasis.Forexample,in2015only9ofthe12fundersreporteddata(forgrantsin2015).


Grants,Studies&Trials

3 HealthResearchWeb(COHRED)

Web-based,interactiveandgrowingsourceofinformationonthestructureandorganisationof research for health in and for LMICs. Organised to provide integrated information onresearchforhealthatcountrylevelandregionallevel inordertostrengthennationalhealthresearchcapability.Userscansearchbycountryforinformationonongoinghealthresearch,healthresearchpriorities,andkeyinstitutions.

National&Regional

Multiplesecondarysources

4 AsiaPacificObservatoryforHealthPoliciesandSystems

Onlinedirectoryofdataaimedatimprovingregionalcollaborationonhealthsystemspolicybyprovidingasinglesourceofdatarelevanttohealthsystemspolicyformembercountries.TheAPO collaboratively identifies priority health system issues across the Asia Pacific region,developsandsynthesizesrelevantresearchtosupportandinformcountries’evidence-basedpolicydevelopment;andbuildscountryandregionalhealthsystemsresearchandevidence-informedpolicycapacity.

National Multiplesecondarysources

5 WHOInternationalClinicalTrialsRegistryPortal(ICTRP)&RegistryNetwork

EstablishedfollowingtheMinisterialSummitonHealthResearchinMexicoCityinNovember2004as"anetworkofinternationalclinicaltrialsregisterstoensureasinglepointofaccessandthe unambiguous identification of trialswith a view to enhancing access to information bypatients,families,patientgroupsandothers".ThemainaimoftheWHOICTRPistofacilitatetheprospectiveregistrationoftheWHOTrialRegistrationDataSetonallclinicaltrials,andthepublicaccessibilityofthatinformation.28TheWHORegistryNetworkprovidesprospectivetrialregistrieswithaforumtoexchangeinformationandworktogethertoestablishbestpracticeforclinicaltrialregistration.


RegisteredTrials

6 ClinicalTrials.Gov(USNationalLibraryofMedicine;NIH)

ClinicalTrials.govisaWeb-basedresourcethatprovidespatients,theirfamilymembers,healthcareprofessionals,researchers,andthepublicwitheasyaccesstoinformationonpubliclyandprivatelysupportedclinicalstudiesonawiderangeofdiseasesandconditions.InformationonClinicalTrials.govisprovidedandupdatedbythesponsororprincipalinvestigatoroftheclinical


RegisteredTrials

28https://www.who.int/ictrp/about/en/29MoreaboutCIDACFIOCRUZhttps://cidacs.bahia.fiocruz.br/en/

study.StudiesaregenerallysubmittedtotheWebsite(thatis,registered)whentheybegin,andtheinformationonthesiteisupdatedthroughoutthestudy.Insomecases,resultsofthestudy are submitted after the study ends. ThisWeb site and database of clinical studies iscommonlyreferredtoasa"registryandresultsdatabase."

7 OtherTrialRegistries(Global;Country,&Region-specificClinicalTrialRegistries)

Severalotherregistriesexistwheredataonclinicaltrialsaremaintained.Anumberofthesecountries are part of the WHO Registry Network having obtained recognition by WHO as“PrimaryRegistries’.TheICSTRNisaprimaryclinicaltrialregistryrecognizedbyWHOandICMJEthatacceptsallclinicalresearchstudies(whetherproposed,ongoingorcompleted),providingcontent validation and curation and the unique identification number necessary forpublication. ThePanAfricanClinical Trial registry (PACTR) is a recently developed regionalregistrycurrently fundedbytheEDCTPandmanagedbytheSouthAfricanCochraneCentre(SACC),anintra-muralresearchunitoftheSouthAfricanMedicalResearchCouncil(MRC).


RegisteredTrials

8 Theme-SpecificR&DDatabases

AnumberofplatformsfordatasharingtoaidclinicalresearchcapacitystrengtheningrelevanttoLMICs,usuallyhostedbyR&Dcoordinationmechanismsforthesethematicareas.Examplesincludethe IAVIClinicalTrialDatabase,hostedbythe InternationalAIDSVaccine Initiative(IAVI), a nonprofit scientific organization whose mission is to develop vaccines and otherbiomedicalinnovationsthatpreventHIVinfection.


RegisteredTrials

9 Academic(scientific)databases&searchenginesonhealth&biomedicalresearch

Several platforms exist for finding or accessing articles/publications in academic journals,institutional repositories, archives, or other collections of scientific research. These datasourceshaveholdinformationthatisrelevanttoLMICresearchcapacitystrengthening.Theyinclude Pubmed, a database primarily of references and abstracts on life sciences andbiomedicaltopics;WebofScience,amultidisciplinaryportalthatincludesotherproducts,suchasSocialScienceCitationIndex,ScienceCitationIndex,BiologicalAbstracts&TheZoologicalRecord;ResearchGate, a professional network for scientists and researcherswith to share,discover, and discuss research; and other niche platforms such as the Circumpolar HealthBibliographicDatabase(CHBD)andtheCochraneLibrary.

Individual ScientificPublications

10 CountrySpecificPlatforms(CIDACS–FIOCRUZ,Brazil)29

TheCentreforIntegrationofDataandHealthKnowledge(CIDACS-FIOCRUZ)istoenablestudiesand research, the development of new investigativemethodologies, and the promotion ofscientifictraining,viainterdisciplinaryprojects,andbasedontheintegrationoflargedatabases(“bigdata”).

National Multiplesources

30MoreaboutG-FINDERherehttp://www.policycures.org/gfinder.html31MoreaboutRESINhere:http://researchinvestments.org/32IHMEFGHStudyvisualizationdatacanbefoundhere:https://vizhub.healthdata.org/fgh/33Ibid33

11 FinancialTrackingPlatforms(G-FINDER30,RESIN31,IHME32)

G-FINDER(2008–present)TheG-FINDERprojectpublishes reportsonglobal investment intoneglecteddiseaseR&Dandmaintainsapublicdatabaseofsuchinvestments.TheInstituteforHealth Metrics and Evaluation undertakes a Financing Global Health (FGH) study (2009–present).Thestudyreportsontrendsindevelopmentassistanceforhealth,aswellasotherhealthspending,andprovidesapublicdatabaseofspendingdata.TheResearchInvestmentsinGlobalHealth (ResIn) study is ananalysisof global investments inhealth researchand isbasedattheUniversityofSouthampton.RESINwasawardedfundingfromtheBill&MelindaGates Foundation to cover infectious disease research investment analyses across the G20countries,withaparticularfocusontheinvestmentportfoliosrelatingtopneumonia,neonatalinfectiousdiseaseandmaternalimmunization33.

National Fundingflows

Table3-Platformswithdatarelevanttoclinical/healthresearchcapacitystrengtheninginLMICs

3.3 INVENTORY/REVIEWOFEXISTINGMECHANISMSFORIMPROVINGCOORDINATION

ThelandscapeforresearchcapacitystrengtheningforLMICsisbroadandhighlyfragmented,withseveralmechanismsinexistenceaimedatenhancingsynergy,coordinationandeffectivenessofinvestmentsinclinicalresearchindevelopingcountries.Thissectionofthepaperaimstoprovideaninventoryofthesemechanisms(moredetailsprovidedintheappendix)andreviewtheirscopevis-à-visthescopeofwhatcould be envisaged as an effectivemechanism, as established in Section 2.4.1 based on stakeholderinterviewscompletedinthepreparationofthisbackgroundpaper.Anattemptisalsomadetoprovideaperspectiveonhowtheyarepositionedvis-à-visasetofkeyfactorsrelatedtoinstitutionalcomplexity,whichwasestablishedinSection2.3asamajorbarriertoimprovingcoordination.

Afewkeypointsarenoteworthyinrelationtothesummaryoffindingsontheinventoryofmechanismsreflectedinthetablebelow.

§ The term ‘mechanism’ is used to refer to any initiative set-up or embarked upon with theobjectiveof improvingsynergy,betweenandamongmultipleorganisations involvedwithanyaspectofresearchcapacitystrengthening,withthepotentialtoimpactnationalresearchsystemsin LMICs.Note that emphasis here is placedon the primacy of capacity strengthening in themandateof the initiative, as against, for example thedevelopmentof newproducts. The listprovidedbelowalsofocusesonmechanismsthataremulti-dimensionalintermsoftheaspectsofcoordinationthat theyare involvedwith.Thisexplains theomissionofpredominantlydatasharingplatforms(alreadyprofiled)fromthelistbelow,withoutprejudicetothefactthattheseplatformsareindeedcoordinationmechanisms,giventhewidelyacknowledgedcentralityofdatasharingandinformationsymmetrytohealthresearchcoordination.

§ Availablemechanismsareorganizedinseveralways:byspecificdisease,bybroadareaofdiseasebyproduct(e.g.vaccines),orbyregion.Manyinitiativesarecross-cuttinginnature,seekingtoimprove coordination at the level of national or international health policy. The list ofmechanismsindicatedbelowisinclusiveofalltheavailablecategories.

§ ThefactorsunderScopeareexplainedinSection2.4.1

§ ThefactorsunderInstitutionalcomplexityareexplainedasfollows:i. Institutionalremit–theextenttowhichthemechanism’sprimaryremitenablesittoworkonLMICprioritiesasagainstotherareasofclinicalresearch/capacitystrengthening

ii. Degree of influence – the extent towhich themechanism can influence participatingorganizationstoadapttheirinternalsystemsand/orprocedurestoalignwithdecisionscollectivelyreached

iii. Neutrality–Theextenttowhichthemechanismis(orperceivedas)freeofcontrollinginfluencebyone(orasubsetof)participants

Scope InstitutionalComplexity

StrategicAlignment

InformationSharing-Capacity

InformationSharing-RCS

ResourceAllocation

Accountability InstitutionalRemit Deg.ofInfluence Neutrality

TDR

ESSENCE

GlobalAMRR&DHub

GlobalAllianceonChronicDiseases

UKCDR

PanAmericanHealthOrg.

WestAfr.HealthOrg.

European&Dev.CountriesCTPartnerships(EDCTP)

JointProgrammingInitiativeonAMR

Intl.FederationofPharmaManufacturers&Associations

ProductDevt.PartnershipsFundersForum

ProgramofR&DinHumanReproduction(HPR)

GlobalCoordinationMechanismonR&DBlueprint

InstitutePasteur CoalitionforEpidemicPreparednessInnovations

IndiaAlliance AfricanNetworkforDrugs&DiagnosticsInnovation(ANDI)

SouthAsianForumforHealthResearch

AllianceforHealthPolicyandSystemsResearch(AHPSR)

InternationalForumforResearchDonors(IFORD)

AAS/AllianceforAcceleratingExcellenceinScienceinAfrica

CouncilonHealthResearchforDevelopment(COHRED)

Legend:Green:Applicable/Strong;Amber:NotApplicable/Weak;Blank:WIP

Notetoparticipants:

§ Themappinginthetablebelowismerelyindicativeoftheorganizationalcharacterofthesemechanismbasedonlimitedpubliclyavailableinformationonly.Basedonyourpersonalknowledgeorexperience interactingwiththeorganizationsabove,pleasevalidatetheabovecharacterizationofthesemechanismsintermsoftheirscopeandstanding;andpreparetoshareyourperspectivesasnecessarytoenrichthedeliberationsduringtheconsultationsession.

HeadsofIntl.ResearchOrganizations(HIROS)

SoutheastAsiaInfluenzaClinicalResearchNetwork

MultipleProductDevtPartnerships(PDPs)

Table4-Existingmechanismsandtheirkeyattributes

3.4 SYNTHESISOFKEYFINDINGSONTHELANDSCAPEREVIEW

Thissectionattemptsaninitialsynthesisofthekeyfindingsfromthelandscapereviewpresentedintheprecedingsections.

Keyelementsofthecurrentlandscapeandtheirpotentialimplicationsformechanismdesign

The landscape for assessing clinical research capacity and investing in clinical research capacitystrengthening in LMICs is complex, given the diversity of actors and the differences at national andregionallevel.Fromtheperspectiveofimprovingcoordination,wehighlightthreedefiningelements:

1. Absence of strong nationally-owned systems for assessing/evaluating clinical/health researchcapacityandsharingtheresultsofsuchassessments.There is littleevidencethatLMICgovernments’havesystems inplacetoassessclinical/healthresearchcapacityespeciallyattheinstitutionalornationallevel.Manydevelopingcountries,areyettoproperlyprioritizehealthresearchcapacityaspartofdevelopmentpolicy.Asaresult,thelandscape review shows that strong nationally-owned and driven systems for assessingclinical/healthresearchcapacityarenotcommon. Intheabsenceofnationalsystems,severalregional systems exist inwhich these countries participate,mostly under the auspices of theWHO. These systems tend to be theme specific, e.g. theWHOGlobal Benchmarking Tool forRegulatoryCapacitymeasuresprovidesaframeworkformeasuringnationalregulatorycapacitiesformedicinesandvaccines,whiletheAfrica-specificLaboratoryNetwork(LABNET)doessameforlaboratorynetworkcapacity.Adoptionanduseoftheseframeworksarestillataninfancystage,and theexpectations is that thesewill lead tomorecountry-generateddataonclinical/healthresearchcapacityinLMICs.Thedesignofaneffectivecoordinationmechanismshouldconsiderwaystoimprovethedefinitionofcompetenciesandstandardsthatreflectcapacity,andwaystoencourageusageanduptakeofassessmentframeworksbyLMICs,toincreasetheavailabilityofqualitycountry-generateddataonprevailingcapacityandsimplifygapanalysis/interventiondesign.

2. Useofmultiple,discreteexternallydesignedsystemstoassessclinical/healthresearchcapacityand/orreviewresearchcapacitystrengtheninginvestmentsinLMICswithoutsufficientalignmentinobjectivesanddatasetsusedtoinformsuchassessments/reviews.

Structural gaps in the availability of data from country-based systems have led to a situationwhere there is currently no universally acceptable, singular data source on clinical researchcapacity for low- andmiddle-income countries. As a result, key actors in the health researchecosystem rely primarily on proxy data,which is largely anchored on the volume of previousand/orongoingresearchactivitypercountry intheformofstudies,clinicaltrialsandresearchgrants,beingfundedbysimilaractors.

Thechallengewiththisapproachisthatdifferentactorsinthehealthresearchecosystemhavevaryingneedsforinformationonclinicalresearchcapacityandhavethereforeadopteddifferentapproachestosourcingdataonclinicalresearchcapacity.Thishasledtosignificantinformation

asymmetry and the absence of a unified lens for assessing capacity issues and reachingharmonious decisions that strengthen research capacity in low- andmiddle-income countries(LMICs).Consequently,resourcecapacityconsiderationsforLMICsarenotinformedbyaccurateandconsistent setofdata.Forexample,highvolumeof researchactivity inone institutionorcountryrelativetoanothermayormaynotindicateahigherlevelofexpertiseinoneorganisation,andoftendoesnotyieldanyfurtherinsightsthatcouldinformthedesignofaneffectivecapacitystrengtheninginterventionforthebenefitofthepurportedly‘weaker’institution.

Despite the above, there is recognition that better data transparency on clinical researchinvestments,even ifbasedonproxydatageneratedby largefunderscouldbetransformative.AlongthislineofthinkingmechanismsliketheWorldReport,theGlobalHealthObservatoryandClinicalTrialRegistrieshaveemergedto increasethe levelofdatatransparencyamongst largefundersofhealthresearch,butissuesremainwiththevalueofthedataavailable:

§ Utility valueof existingdata is sometimes skewed to individual researchersandpublicfunders alone, and not easy to use by other ecosystem actors (e.g. limitedavailability/sharingofsite-specificcapacityneededbyprivatefunders).

§ Existing data is too simplistic, and unable to provide an acceptable appraisal ofinstitutionalandcountryclinicalresearchcapacity–dataonaspectsofcapacitysuchasregulatory,ethicalreview,humanresources,laboratoryquality,communityengagementdataparticularlylimitedarenottypicallyintegratedintotheseplatforms

§ Dataquality issuespersistacrossmultipleplatformsduetodifferences indatastorageprotocols,affectingthecompletenessandvalidityofthedata

§ Availabledataisnotsufficientlypredictivevalue-positive,andnotprimarilydesignedtosupportaforward-lookingperspective

Keyconsiderationsrelevanttothisissueincludehowtoaddressthecomplexityquestion,giventhatdata-sharingsystemsthataredesignedtomeettheneedsofallstakeholdersruntheriskofbeingeithertoosimpletosatisfactorilyaddressneedsorbecomingtoocomplextobeefficientlyandcost-effectivelymaintainedandkeptrelevant.Findingtheright-subsetofstakeholderneedsthatcanbemettocreatethemostimpactandtherightsubsetofdatatooptimizeandmakemoremeaningfulwillbecrucial.Alsocriticalisdesigningtherightformatforthepresentationofdatatomaximizeitsutility.Optimaluseofleading-edgevisualizationtechnologieswillbekeytosuccess.

3. Absenceoforganizations/entitiesthathaveabroadenoughremittolead/driveaholisticapproachto coordination, yet structurally and functionally simple enough to navigate the institutionalcomplexitiesinherentinthelandscape

Giventhe institutionalcomplexitiespreviouslydescribed,decidingontheorganizationalentitywithinwhichthismechanismshouldbeembedded,andresolvingimportantquestionsofhowitisgovernedandfundedwithoutnegativelyimpactingitsLMICfocus,organizationalagilityandresponsiveness, and political neutrality are important design considerations. Achievingcollectiveaccountabilityamongstparticipatingorganisationsinawaythatisnon-threateningyeteffective,willbecriticaltosuccess.

Questionsforparticipants(Section3.4)

§ Thissectionsynthesizesthelandscapeanalysisintothree(3)definingelementsandhighlightstheirrespectiveimplicationsfordesigningamoreeffectivemechanism.Whatareyourthoughtsonthis?

§ What other aspects of the landscape should influence how we think about designing theenvisagedmechanism?

§ What kind of mechanism is likely to provide further incentives for investments in capacitybuildingincountriesthatareespeciallyweak?

4 COORDINATIONMECHANISMS:ALTERNATIVEMODELSANDOPTIONSTO

CONSIDER

4.1 OVERVIEW

TheprecedingsectionsofthispaperoutlinethecurrentlandscapeforclinicalresearchcapacityandclinicalresearchcapacitystrengtheninginLMICs,highlightsseveralprevailingissues,andaninitialexaminationofthepotentialimplicationsforthedesignofaneffectivemechanism.Thissectionofthepaperdelvesfurtherintothetopicofmechanismdesign,byexaminingafewpotentiallyusefulcasestudies.

4.2 CASESTUDIES:MODELS&MECHANISMSFORIMPROVINGCOORDINATION

Thecasestudiesprovidedinthissectionwereselectedbasedontheirpotentialusefulnessinprovidingabroadsetofinsightsthatarerelevanttothreekeydesignexpectationsoftheenvisagedmechanism:

1. Higherlevelsofdataaccuracy:Moreaccuraterepresentationofresearchcapacitybasedonreal-time/near real-time verifiable on-the-ground (bottom-up) data, preferably from nationally-owned or managed assessment systems, using an inclusive set of pre-agreed standards andmetrics,asagainstthewideuseofineffectual/misleadingproxydata

2. Effectivedataaggregationandsharing:Higherlevelsofdataavailabilityanddatatransparencyonclinical researchcapacity (perpt.1above), andongoing/plannedclinical researchcapacitystrengtheninginvestments;toinformdecisionmakingonprioritysetting,resourceallocationandinvestmentcoordination

3. Sustainability:Greaterprospectsofsustainedparticipationandsupportduetosuitabilityandease of use by multiple institutions, regardless of institutional complexities and differencesbetweenthem

4.2.1 CaseStudy#1:TheCGIARPlatformforBigDatainAgriculture

TheCGIARPlatformforBigDatainAgriculture34isoneofthreeresearchsupportplatformswhichunderpinandenabletheresearchoftheentiretheCGIARsystem.TheothertwoplatformsaretheExcellenceinBreedingPlatform,whichaimstobecometheone-stopplacetogoforadvice,testedresourcesandbestpracticesforanybreedingprogramtargetingthedevelopingworld;andtheCGIARGenebankPlatform,whichmonitors,test,germinate,multiply,characterize,clean,culture,store,anddistributegermplasmunderhighscientificstandardsofoperation,anddealswith individualrequestsforcropdiversityfromusersworldwideaswellaswithintheCGIAR35.

ThegoaloftheplatformistoharnessthecapabilitiesofBigDatatoaccelerateandenhancetheimpactofinternationalagriculturalresearch.ThePlatformisexpectedtoachievethisthroughpartnershipswith

34CGIARBigDataCoordinationPlatformLeveragingCGIARdata:Bringingbigdatatoagriculture,andagriculturetobigdata;beingtheBigDataCoordinationPlatform:FullProposal2017-2022;CGIAR;201635Formoreinformation,visithttps://www.cgiar.org/research/program-platform/genebank-platform/andhttps://www.cgiar.org/research/program-platform/excellence-in-breeding-platform/

initiativesandorganizationsoutsideCGIAR,bothupstreamanddownstream,publicandprivate. ItwillfocusonpromotingCGIAR-widecollaborationamongstitsresearchcenters,inadditiontodevelopingnewpartnershipmodelswithbigdataleadersglobally.ThePlatformhasthreecoreobjectives:

1. Organize: Support and improve data generation, access, andmanagement across the CGIARsystem

2. Convene: Collaborate and convene globally around big data and agricultural development,providingopportunities and spaces for facilitated virtual collaborationand interactionamongpartnersandstakeholders,andhostingaBigDataConventiontodrivebringkeyactorstoCGIARandvice-versa

3. Inspire:To leadbyexampleand inspire the researchcommunityonhowbigdata candeliverdevelopmentoutcomes,throughinspirationalprojectsthatsolvedevelopmentchallenges

Thestrategicplanunderpinningtheplatformrecognizesthatasafirstandnecessarystep,CGIARmustgetitsownhouseinorderwithrespecttodata.Henceitprioritizedthethreeobjectivesinsequence,withobjective#1focusedonacquiringtheinfrastructure,toolsanddataculturetosucceed,inbothtechnicalandmanagerialdimensions.TheminimumsuccessfactorforthisobjectiveiscompliancewiththeopenaccessandopendatapolicyofCGIAR,ensuringdonorsandinvestorsinCGIARcanbeconfidentthatdataisbeingmanagedandsharedeffectivelyacrossallCGIARoperations.

The “Organize” module of the platform drives the execution of objective #1, by building capacitythroughoutCGIARtogenerateandmanagebigdata,assistingCGIARanditspartners’effortstocomplywithopenaccess/opendataprinciplestounlockimportantresearchanddatasets36.Thefollowingfocusareasofitsworkareparticularlynoteworthy:

1. Establishingaprocess,supportingcompliance,andenablingadatacultureinalignmentwiththeCGIAROpenAccessandDataManagement(OADM)Policy37.

2. Investing in an online tool (Global Agriculture Research Data Innovation and AccelerationNetwork (GARDIAN) 38 that enables users to easily search and discover open datasets andpublications across databases at all CGIAR Centers, with the intention of making this a keymechanismformonitoringandmeasuringcompliancewiththeCGIARopenaccesspolicy.

3. ExecutingthemandatetooftheplatformtoproduceinternationalpublicgoodsandensurethattheseareopenviaFAIRprinciples–thatis,thedataareFindable,Accessible,InteroperableandReusable.Thisenablesthedatatobeusedtoenhanceinnovation,impact,anduptake.

4. SupportingdatamanagersatresearchcenterswithaDataManagementSupportPack39.Thistoolwasdesignedtohelptheresearchcommunityproducehighquality,reusable,andopendatafromresearchactivities.Itconsistsofdocuments,templates,andvideoscoveringarangeofaspectsrelated to data management and interoperability, ranging from overarching concepts andstrategies through today-to-day activities.Also runs amonthlywebinar series to support themanagementand“FAIRification”ofinformationresources.

36Informationdirectlyreferencedfromhttps://bigdata.cgiar.org/organize/37Ref:https://www.cgiar.org/how-we-work/accountability/open-access/38http://gardian.bigdata.cgiar.org/#!/39Moreinformationonthedatamanagementsupportpackcanbefoundhere:https://ccafs.cgiar.org/data-management-support-pack

5. Developingdataprivacyandethicsguidelinestoensurethatdatasharingandusecomplywithethicalstandardsthatprotectthosewhocouldbevulnerabletoexploitation

6. Investing in learningand capacitybuilding initiatives to acceleratedata sharing aswell as keyanalyticcapabilitiesacrosstheCGIARviamultiplemeans,toencourageincreasedinvestmentindevelopingdatarepositoriesandsoftwareinfrastructuretobuildopendatasharingandstoragecapabilities;andinvestmentinnewstaffrolesfordatacuration,collection,andanalysis.

Leadership,managementandgovernance:ThePlatformisdesignedtobeco-ledbytwoofitsresearchcenterswith the strongest track record for data-driven research - CIAT and IFPRI -with bothCenterssharingresponsibility for thePlatformtodeliver.Leadership isprovidedthrougha leanSecretariat, toconsistofaBigDataCoordinator,acommunicationandengagementspecialist,andmodestadministrativesupport.TheestimatedannualbudgetforthesecretariatisUS$250k.AnExecutiveManagementTeamisenvisagedtomeetbimonthlytoactivelymanagethePlatform,andaSteeringCommittee(SC)isproposedtoprovideoversightanddirection,formallyreportingtotheCIATBoard,giventhatCIATisthesignatoryto the performance contractwith the CGIAR SystemOffice and has overall fiduciary and operationalresponsibilityforthePlatform.ThecostoftheSCisestimatedtobe<$20,000peryear.AnInternationalAdvisoryBoard(IAB)willalsobesetup,andwillmeetface-to-faceonceperyear,andvirtuallyonceperyear,toexplicitlyexaminehowtheCGIARPlatformonBigDataconnectseffectivelywithotherglobalandregionalefforts.

4.2.2 CaseStudy#2:TheUNOfficeoftheCoordinationofHumanitarianAffairs(UN:OCHA)

TheOCHAisthepartoftheUnitedNationsSecretariatresponsibleforbringingtogetherhumanitarianactorstoensureacoherentresponsetoemergencies.OCHAalsoensuresthere isa frameworkwithinwhicheachactorcancontribute to theoverall responseeffort. OCHA’smandatestems fromGeneralAssembly(GA)resolution46/182ofDecember1991,whichstates:“TheleadershiproleoftheSecretary-General is critical and must be strengthened to ensure better preparation for, as well as rapid andcoherentresponseto,naturaldisastersandotheremergencies.”Tothisend,italsoestablishestheroleoftheEmergencyReliefCoordinator(ERC),whoworkswiththeSecretary-GeneralandtheInter-AgencyStandingCommittee(IASC)inleading,coordinatingandfacilitatinghumanitarianassistance.OCHAistheofficethatprovidessupporttotheERCandtheSecretary-GeneraltomeettheleadershipandcoordinationresponsibilitieschartedinGAresolution46/182.

OCHA coordinates humanitarian action to ensure crisis-affected people receive the assistance andprotectiontheyneed.Itworkstoovercomeobstaclesthatimpedehumanitarianassistancefromreachingpeopleaffectedbycrises,anditprovidesleadershipinmobilizingassistanceandresourcesonbehalfofthehumanitariansystem.Itisnotanoperationalagencydirectlyengagedinthedeliveryofhumanitarianprograms,and itsaddedvalue isasanhonestbroker, facilitator, thought leaderandglobaladvocate,providingsupporttothehumanitariansystem.Infulfillingitscoordinationmandate,OCHAisguidedbythehumanitarianprinciplesofhumanity,neutrality,impartialityandindependence.OCHAisalsoguidedbyanumberofnoteworthyprinciples:

§ Diversity–ensuresthatallstakeholdershavearoleinsavingandprotectinglivesandalleviatinghuman suffering by promoting coordination mechanisms and processes that are open forparticipationtoallrelevantlocalandglobalhumanitarianactors.

§ Trust -Believes thatmutual trust is the foundation for successfulpartnerships,hence itsnon-programmaticcoordinationroleenablesittofulfilitsuniquefunctionasanhonestbroker.

§ Nationalandlocalownership-WorksinfullrecognitionthatMemberStatesretaintheprimaryresponsibility for the provision and coordination of humanitarian aid to affected populations.Hence it focuses on augmenting national and local coordination capacities yet staying guidedforemostbytheinterestsofpeoplewhoneedhumanitarianassistance.

OCHA, working with its partners, contributes to effective humanitarian response through five keyfunctions,withcoordinationandinformationmanagementatthecoreofitsoperationalframeworkforeffectivecoordination(Reffig5below)

1. Coordination - toexpand the reachofhumanitarianaction, improveprioritizationand reduceduplication

2. Humanitarian Financing – to mobilizeandengage the full rangeof financinginstruments,mechanismsandpartnersto ensure that growing humanitarianneedsaremet

3. Advocacy - raises awareness offorgotten crises, promotes respect forinternational humanitarian law (IHL),andbrings thevoicesofcrisis-affectedpeopletotheforefront

4. Policy – to set the agenda forhumanitarian sector reform andeffectivenessinresponsetochangesinthegloballandscape,andtoincreasecapacitiesofnationalGovernmentsandlocalactors

5. Information management - provides information management services to the humanitariancommunitytoinformaneffectiveresponse,bygathering,sharingandusingdataandinformation,tounderpincoordination,decision-makingandadvocacy

For thepurposesof thisbackgroundpaper, the following focusareasofOCHA’sworkareparticularlynoteworthy:

§ Backboneforvariouscoordinationmechanisms:OCHAservesasthesecretariatforcriticalinter-agency coordinationmechanisms related tohumanitarian assistance such as the Inter-AgencyStandingCommittee,rapid-responsetools,suchastheUnitedNationsDisasterAssessmentandCoordinationsystem,andtheInternationalSearchandRescueAdvisoryGroup.ThisroleallowsOCHAtodrawuponitsexperiencetoaffectanumberofkeyprocessesandproceduresthroughwhich humanitarian response capacity building, response preparedness, and responsecoordinationeffortsareexecuted.

Figure1-OCHAHumanitarianProgrammeLifecycle

§ FinancialTrackingService:OCHArunsandmanagestheFinancialTrackingService,whichaimstopresent a complete picture of all international humanitarian funding flows, collating data onhumanitarian funding flows submitted by Government donors, UN-administered funds, UNagencies, NGOs and other humanitarian actors and partners, including the private sector. Itverifiesandcombinesthesereportsusingaconsistentmethodology,ensuringthatdataisfullycomparableandpresentedasaseamlesswhole.TheFTSiscontinuouslyupdatedandprovidesvisibility on financial contributionsto humanitarian activities, flowsbetween donors and recipientorganizations, and timelymonitoring of funding progressagainsthumanitarianresponseplanand appeal requirements. Thisservice supports the transparencyand accountability of thehumanitariansystemandfacilitatesresource mobilisation: it informsreal-time decision-making at bothnationalandgloballevelsacrossallhumanitarian emergencies andactors, focusing not just oncontributions but also on theallocationanduseoffunds.Thoughbased on a voluntary reportingmechanism, reporters of data tothe FTS are encouraged to alignwith the International AidTransparency Initiative40 standard.AnillustrationoftheFTSworkflowisprovidedinFig6.

§ TheHumanitarianDataExchange(HDX)41:TheHDXisanopenplatformforsharingdataacrosscrisesandorganisations.LaunchedinJuly2014,itsgoalistomakehumanitariandataeasytofindanduseforanalysis.ItisManagedbyOCHA’sdedicatedCentreforHumanitarianData42,whichisinTheHague.TheHDXteamincludesOCHAstaffandseveralconsultantswhoarebasedinNorthAmerica,EuropeandAfrica.TheCentreisfocusedonincreasingtheuseandimpactofdatainthehumanitarian sector and its desired outcomes include: speeding-up the flow of data fromcollectiontouseandensuringgreaterreal-timevalueofdata;optimizingaccesstoshareddatainfrastructure;andensurethatdataisusedbetterandmoreoftenbythepeoplewhoaremakingcritical decisions in a humanitarian response. The Centre’s software and standards are open

40MoreinformationabouttheInternationalAidTransparencyInitiativeStandardcanbeaccessedathttps://iatistandard.org/en/iati-standard/41MoreinformationabouttheHumanitarianDataExchangecanbeaccessedathttps://data.humdata.org/faq42MoreinformationabouttheCentreforHumanitarianDatacanbeaccessedathttps://centre.humdata.org/

Figure2-HowtheFTSWorks

sourcewithallcodemadeavailable throughGitHub43. Inadditionto theHDX, theCentrealsomanagestheHumanitarianExchangeLanguage(HXL),adatastandardtohelpeasedataexchangeandimprovetheanalyticvalueofdata.

Financing & Budget: OCHA is reliant on voluntary contributions fromMember States, the EuropeanCommission,andotherdonorsforitsfunding,asonly5percentofitsannualbudgetisfundedfromtheUnitedNationsRegularBudget.OCHA’s2018extrabudgetary(XB)openingbudgetwas$240.8million,representingadecreaseof$34million,or12percentcomparedwiththe2017openingbudgetof$274.8million.OCHA’sadministrativebudgetisfundedbyprogramsupportcostsleviedontheXBat7percent(approx.$16.85mfor2018).

4.2.3 CaseStudy#3:Vivli–TheCenterforGlobalClinicalResearchData

Vivli isan independent,non-profitorganizationthathasdevelopedaglobaldata-sharingandanalyticsplatformwhichfocusesonsharingindividualparticipant-leveldatafromcompletedclinicaltrialstoservethe international research community. Its stated mission is “to promote, coordinate, and facilitatescientific sharing and reuse of clinical research data through the creation and implementation of asustainableglobaldata-sharingenterprise….actasaneutralbrokerbetweendatacontributor,datauserandthewiderdatasharingcommunity”.VivlievolvedfromaprojectofTheMulti-RegionalClinicalTrialsCenterofBrighamandWomen’sHospitalandHarvard(MRCTCenter)44toenhanceaccesstoclinicaltrialsdatabypromotingdatasharingandtransparency.

TheVivli platform includes an independentdata repository, an in-depth search engine and a secureresearchenvironment.ItsplatformprocessisillustratedinFig7below.

Figure3-VivliPlatformProcess

DatasharingontheVivliplatformislinkedtomembership,requiringasignedDataContributorAgreementand a signed Vivli Data Use Agreement. The data package includes protocol, anonymized individualparticipant-level dataset, data dictionary, and statistical analysis plan at a minimum; with additionalelements such as annotated case report forms, clinical study report, and analysis ready datasets are

43Refertohttps://github.com/OCHA-DAP44Findmoreinformationathttps://mrctcenter.org/

optional. Anonymization of the data is offered as a paid service, as with storage and review by anindependentreviewpanel.

Vivli is operated as a non-profit organization and is currently funded by a four charitablefoundations/trustsandthePharmaceuticalResearchandManufacturersofAmerica(PhRMA).Itsmodelis founded on several strategic partnerships, and its strategic partners are Microsoft (core platformtechnologyprovider),Ropes&Gray(corporate,regulatoryandIPcounsel),PrivacyAnalytics(datasecurityandanonymization),WellcomeTrust(IndependentReviewPanel),Cochrane(expertiseforsynthesisofresearchevidence),andDataCite(digitalidentifiersforscientificstudies).

4.2.4 Comparingthethreemodelsreflectedinthecasestudies

Thecasestudiespresented intheprecedingsectionshighlightthreemarkedlydifferentapproachestoimprovingcoordinationbetweenmultiplestakeholdersincontextswheredatagovernance,transparencyandsharingiscentraltosuccessfulcoordination.Table2belowattemptstocomparethethreemodels,vis-à-vistheearlierhighlighteddesignprinciplesoftheenvisagedmechanism:

Table5-Keyattributesofeachmodel

Higherlevelsofdataaccuracy

Effectivedataaggregationandsharing

Sustainability

CaseStudy#1:CGIARBigDataPlatform

§ Highemphasisonqualityofdatatosupportadvancedanalytics

§ Emphasisondatacollection/storageinfrastructureandanalyticcapabilitiesatsource(researchinstitutions/centers)

§ Promotionofcommonstandards(Open/Access/OpenDatapolicy)

§ Promotionofcommonprinciples(FAIRPrinciples)

§ Technicalsupportfordatamanagers(OpenDataManagementPack)

§ Useofintegratedsearchplatform(GARDIAN)

§ Leanmanagementandgovernancestructure

§ Fiduciaryandoperationalresponsibilityresidinginasingleresearchcentre

CaseStudy#2:UnitedNations:OCHA

§ Cleardistinctionbetweendataonfinancialflows(FTS)anddataonhumanitarianprojects(HDX)

§ Bottomup(country-led)processforidentifyingfundingrequirements

§ Centralizedentityresponsibleforcuration

§ Useofopensourcetechnologyandcommonplatform(HDX)

§ Promotionofcommonstandards(IATI)

§ Promotionofcommonsyntaxfordatadocumentation(HXL)

§ Dedicatedcentreforhumanitariandata(distinctfromfinancialtrackingservice)

§ Leanmanagementandgovernancestructure

andtriangulationofdatafrommultiplesources

CaseStudy#3:VivliCentreforClinicalResearchData

§ Highlevelsofdataqualitycontrolatthepointofdatacontribution

§ Useofenforcedagreementsondatauseandtightlypre-defineddatapackagesanddatasets

§ Datanotavailable

Questionsforparticipants(Section4)

§ What lessons canwe glean from the above case studies that are applicable to designing amechanismforbettercoordinationofclinical/healthresearchcapacitystrengtheninginLMICs?

§ Whatothermodelsdoyoureckonwecanlearnfrom?(pleasepreparepointsthatcanbesharedduringgeneraldiscussionattheMarch2019consultation)

5 RECOMMENDINGAMOREEFFECTIVEMECHANISM:GUIDINGPRINCIPLESANDSTRATEGICFRAMEWORK

5.1 OVERVIEWANDGUIDINGPRINCIPLES

Effective deliberations to recommend a better mechanism for improving coordination will requirestakeholderalignmentaroundthedesiredendstatethatthemechanismisexpectedtobringabout,andagreementonasetofguidingprinciples.Thissectionofthepaperproposeslanguageontheaboveforconsideration,and laysoutaframeworktoguidethedevelopmentofrecommendationsattheMarchconsultation.

Desiredend-statethatthemechanismshouldbringabout(proposedlanguageforreviewattheMarch2019consultation):

‘Theprimaryobjectiveoftheenvisagedmechanismistooptimizeaccuracy,transparencyandavailabilityofdataonclinical/healthresearchcapacityandresearchcapacitystrengtheninginLMICs,toexpandthescaleandreachofinvestments,improveprioritization,andreduceduplication,ensuringtheemergenceofnationalhealthresearchsystemsthatcanmeettheneedsoftheirrespectivepopulations’

Guidingprinciplesfordesigningtheenvisagedmechanism:

1. Ajourney,notadestination:Optimizingdataaccuracy,transparencyandavailabilitytoimprovecoordination on research capacity strengthening should be regarded as a journey, and not adestination.Decisionsonobjectives,scope,andoutputsforthemechanismmustthereforebeconsideredacrossthelong-,medium-,andshort-term,withappropriateemphasisgiventogettingthe sequencing right and resolving interdependencies. In addition, principles, standards, andprocedures,shouldbedefinedtoservethelong-terminterestsofthescientificcommunity.

2. Modularthinkingandportablemilestones:Thediversityofstakeholderneedsandexpectationsfrom a mechanism, coupled with the limited success of previous attempts necessitates anapproach to design that focuses on achieving recognizable early results efficiently and cost-effectivelyforacriticalsub-setofstakeholders.

3. Avoidingpotential landmines:Thedesignof themechanismmust takeduecognizanceof theinstitutional complexities in the landscape,whichpose a significant risk to the success of anymechanismifnotproperlyconsidered.Stakeholdersmustbewillingtothinkbeyondconventionalnormsinallocatingresponsibility/accountabilityforvariousaspectsoftheenvisagedmechanismamongstdifferentactors.

5.2 PROPOSEDFRAMEWORKFORCONSIDERINGOPTIONS&ALTERNATIVES

Thissectionofthepaperprovidesapracticalguideforusingtheinformationprovidedandreferencedthroughout the background paper to inform participant preparation ahead of the March 2019consultationsessionandenableefficientdeliberationsatthesessionproper.

Figure4-Frameworktoguideuseofthebackgroundpaperforpreparation

Basedontheaboveframework,adeliberation/outputworksheetthatcouldbeusefulatthesessionisprovided below, along with an illustrative framework for the consideration of strategic options andalternativeswithrespecttotheenvisagedmechanismthatmaybeuseful indiscussionsrelatedtothescopeandserviceofferings,deliverymodel(s)andorganizationmodel(s).

Figure5-Deliberation/outputworksheet(proposal,subjecttomodification)

Table6-Illustrativeframeworkfortheconsiderationofalternatives

45MoreonGARDIANhereathttp://gardian.bigdata.cgiar.org/

1 2 3 4 5 ?Requirements InvestmentTracking&

AnalyticsServiceInstitutional&NationalHealthResearchCapacityStandards

Institutional&NationalHealthResearchCapacityDashboard

QualityClinicalTrialSiteSupportService

BigDataPlatformforClinicalResearch

?

Description/Objective

§ StrictlyfortrackingandvisualizinginvestmentflowintoLMICclinicalresearch/researchcapacitybuildingbylargeglobalfunders

§ Definitionandmanagementofstandardsforbottomupassessmentofinstitutionalandnationalresearchcapacities

§ Strictlyforvisualizingandreportingoncountry-ledcapacityassessmentsbasedonthestandardsdefinedandmaintainedbytheWHO(Ref2)

§ Strictlyforsharingverifiedsiteleveldatathatenablesresearchorganizationstoevaluatesite-levelreadinessforclinicaltrialsanddeterminedetailedcapacitybuildinginvestmentsrequired

§ Optimizationofavailabledataacrossclinicaltrialregistriestoincreasetheirsuitabilityforadvancedanalyticsandtheiroverallvalueandusability

§

PrimaryUsers/Beneficiaries

§ Largeglobalhealthdonors

§ LMICHealthAuthorities

§ LMICresearchinstitutions

§ LMIChealthAuthorities§ GlobalhealthAuthorities

§ Allhealthresearchstakeholders

§ Privateindustry§ Internationalresearchorganizations

§ CROs

§ Researchers§ Researchorganizations

§

Deliverymodel § Adoptionofcommonresearchreporting/financialmgt.softwarebyallinstitutessupportedbyparticipatingfunders

§ Technologyenableddedicateddatamanagementandanalyticsteam

§ Review,publishingandmaintenanceofcompetenciesandstandardsforassessingcapacityatinstitutionalandcountrylevel

§ Dataaggregationplatformsupportedbydedicateddatamanagementandanalyticsteam

§ Encouragetheemergenceofclinaltrial‘broker’organisationswhoworkwithtrialsitesinLMICstoassessreadiness,andrecommendsite-levelcapacityinvestments

§ Datasharingplatform

§ Adoptionofcommonopenaccessandopendatamanagementstandardsforclinicalresearch

§ Dataaggregationandanalyticsplatform(likeGARDIAN45)

§

Hostorganization

§ Couldbehostedwithinaresearchinstitution

§ WHO § CouldbeincorporatedintotheGlobalHealthR&DObservatory

§ Decentralized(multiplecompaniescanofferserviceanduploaddata)

§ CouldbeincorporatedintotheWHOICTRP

§

Funding § Jointlyfundedbyparticipatingfunders

§ WHO § WHO § Jointlyfundedbyindustry

§ WHO/InternationalHealthSystem

§

Governance § CouldbegovernedbyESSENCE,givenitsmulti-stakeholder,politicallyneutralstatus

§ WHO § WHO § Couldbegovernedbyindustryassociatione.g.IFPMA

§ CouldbegovernedbyESSENCE,givenitsmulti-stakeholder,politicallyneutralstatus

6 BIBLIOGRAPHY/REFERENCES1. AbdulGhaffar,CarelIJsselmuiden,FabioZicker.ChangingMindsets:ResearchCapacitystrengthening

inlowandmiddle-incomecountries.CouncilonHealthResearchforDevelopment(COHRED),GlobalForum for Health Research (GHFR) and UNICEF/UNDP/World Bank/WHO Special Programme forResearchandTraininginTropicalDiseases(TDR);2008

2. Academy of Medical Science. Strengthening clinical research capacity in low and middle-incomecountries:3-4July2017Workshopreport.AMS;2017

3. AjoyDatta, Louise ShaxsonandArnaldoPellini.Capacity, complexityand consulting: Lessons frommanagingcapacitydevelopmentprojects.OverseasDevelopmentInstitute(ODI);2012

4. BennettS,GlandonD,RasanathanK.Governingmultisectoralaction forhealth in low-incomeandmiddle-income countries: unpacking the problem and rising to the challenge. BMJ Global Health2018;3:e000880.doi:10.1136/bmjgh-2018-000880

5. CIATandIFPRI(2016).CGIARBigdatacoordinationplatform.ProposaltotheCGIARFundCouncil,31March,2016. InternationalCenter forTropicalAgriculture (CIAT),Cali,Colombiaand InternationalFoodPolicyResearchInstitute,WashingtonDC,UnitedStatesofAmerica.

6. ESSENCEGoodpracticedocumentseries.Sevenprinciplesforstrengtheningresearchcapacityinlow-andmiddle-incomecountries:simpleideasinacomplexworld.ESSENCEForHealthResearch;2014

7. ESSENCE Good practice document series. Six practices to strengthen evaluation of Global HealthResearchforDevelopment.ESSENCEForHealthResearch;2016

8. ESSENCE Good practice document series. Planning, Monitoring and Evaluation Framework forResearchCapacityStrengthening.ESSENCEForHealthResearch;2016RevisedEdition

9. FranzenSRP,ChandlerC,LangT.Healthresearchcapacitydevelopmentin low-andmiddle-incomecountries: realityor rhetoric?Asystematicmeta-narrative reviewof thequalitative literature.BMJOpen2017;7:e012332.doi:10.1136/bmjopen-2016-012332

10. Joel G. Breman, Kenneth Bridbord, Linda E. Kupfer, Roger I. Glass, Global Health: The FogartyInternational Center, National Institutes of Health: Vision and Mission, Programs, andAccomplishments;FogartyInternationalCenter,NationalInstitutesofHealth

11. Joses Muthuri Kirigia, Martin Okechukwu Ota, Marion Motari, Juliet Evelyn Bataringaya, PascalMouhouelo.NationalhealthresearchsystemsintheWHOAfricanRegion:currentstatusandthewayforward.HealthResearchPolicyandSystems;2015

12. KäserM,MaureC,HalpaapBMM,VahediM,YamakaS,LaunoisP,etal. (2016)ResearchCapacityStrengthening in Low and Middle Income Countries – An Evaluation of the WHO/TDR CareerDevelopment Fellowship Programme. PLoS Negl Trop Dis 10(5): e0004631.doi:10.1371/journal.pntd.0004631

13. MarkHalle,AdilNajam,andRobertWolfeBuildinganEffectiveReviewMechanism:LessonsfortheHLPF.InternationalInstituteforSustainableDevelopment(IISD);2014

14. NationalAcademiesofSciences,Engineering,andMedicine2017.IntegratingClinicalResearchintoEpidemic Response: The Ebola Experience. Washington, DC: The National Academies Press.https://doi.org/10.17226/24739

15. PanAmericanHealthOrganization.ReportonStrengtheningResearchCapacitiesforHealthintheCaribbean, 2007-2017. Washington, D.C.: PAHO; 2017. Available at http://iris.paho.org/xmlui/handle/123456789/34342.

16. RaghibAli,Alexander Finlayson.Building capacity for clinical research indeveloping countries: theINDOXcancerresearchnetworkexperience.OnbehalfoftheINDOXCancerResearchNetwork;2012

17. Roderik F. Viergever; Themismatch between the health research and development (R&D) that isneededand theR&D that isundertaken: anoverviewof theproblem, the causes, and solutions .CoAction;2013

18. WorldHealthOrganization.TheWHOstrategyon research forhealth.WorldHealthOrganization;2012

19. WorldHealthOrganizationonbehalfoftheSpecialProgrammeforResearchandTraininginTropicalDiseases. TDR strategy 2018-2023: building the science of solutions. Geneva: World HealthOrganization;2017.License:CCBY-NC-SA3.0IGO.

20. WorldBank.Money&Microbes–StrengtheningClinicalResearchCapacitytoPreventEpidemics.TheInternationalVaccinesTaskForcesupportedbytheWorldBankGroupandtheCoalitionforEpidemicPreparednessInnovations;2018

21. World Health Organization. Strategy on Health Policy and Systems Research: ChangingMindsets.WorldHealthOrganization;2012

22. WorldHealthOrganization.Researchanddevelopmenttomeethealthneedsindevelopingcountries:strengtheningglobalfinancingandcoordination:reportoftheconsultativeexpertworkinggrouponresearchanddevelopment:financingandcoordination.WorldHealthOrganization;2012

23. World Health Organization. Global strategy and plan of action on public health, innovation andintellectualproperty.WorldHealthOrganization;2012

24. World Health Organization. Research & Development Coordination and Financing: Report of theReportoftheExpertWorkingGroup.WorldHealthOrganization;2012

7 APPENDIX

7.1 KEYINFORMANTINTERVIEWSTable7:Investmentinresearchcapacitystrengtheningbytypeandlevelofcapacity

Sn Name Institution/DesignationCompleted1 PeterKilmarx FogartyNIH2 HannahAkuffo SIDA3 SimonKay WellcomeTrust4 LindaKupfer FogartyNIH5 BradWilken GatesFoundation6 OleOlesenEDCTP EDCTP7 NadiaKhelef InstitutePasteur,France8 GarryAslanyan Coordinator,ESSENCE9 NicoleLurie CEPI10 VaseeMoorthy WHO/GCM11 Dr.ThabiMaitin MRCSouthAfrica12 Dr.RodrigoCorrea-Oliveira Fiocruz,Brazil13 Dr.LuisGabrielCuervo PAHO14 AnneKelso GACD15 JohnReeder TDR16 MichaelCheetham WorldReport17 TonyTse USNLMClinicalTrials.Gov18 YasoKunaratnam UKCDR19 MargaretMcCluskey USAID/IAVI20 MatthewBarnhart USAIDIAVI21 NickDay Wellcome/SEAsiaClinicalResearchCentres22 ThyPham SeniorProgramOfficerGatesFoundation(GH&AAS)23 AdamaIbrahim EmergingMarketsQualityTrials24 AdamTaghreed GlobalObservatoryonHealthR&D

25 KaramGhassan ICTRP2 NotYetCompleted1 KabirSheikh APHSR2 AnnaThorson HRP3 AndreasLois WHOGlobalHealthEthics4 RESIN UniversityofSouthampton5 NickChapman G-Finder6 Gerald“Jerry”Keusch UniversitySchoolofMedicine7 MukeshChawla WorldBank8 AnnaRuddock WellcomeTrust9 Dr.GlendaGray MRCSouthAfrica10 Prof.BalramBhargava ICMR(IndianCouncilofMR)11 ValSnewin DHSC,UK12 JenniferStuart DHSC,UK13 ProfessorTrudieLang TheGlobalHealthNetwork14 ShahidJameel ED,IndiaAlliance15 RogerCoker ExpertSEAsia16 SamFranzen ExpertLMICClinicalTrials17 LizBohm AMS18 ImeldaBates LSTM19 DrMartaTufet ED,UKCDR20 DrPeterDukes AfricaResearchExcellenceFund

7.2 DEFINITION/CHARACTERIZATIONOFRC&RCSTable8:Investmentinresearchcapacitystrengtheningbytypeandlevelofcapacity

WhoseCapacity? WhatCapacity?Demandresearch Produceknowledge Useevidence

Individual § Leadershipforhealthresearch § Disciplinaryknowledgeandexpertise§ Researchtechniquesandmethodologies

§ Useofresearchinpolicyandpractice

Institutional § Organizationalculture§ Institutionalleadership§ Institutionalindependence§ Externalcollaboration

§ Criticalmassofresearchstaffandsupportstaff§ Infrastructure(hard)

o Officespaceandequipmento Laboratoryandlaboratory

equipment§ Infrastructure(soft)

o Datamanagement§ Infrastructure(enabling)

o Powero Connectivityo Transportation

§ Processandqualitymanagementstandards

o Ethicalreviewo GoodPractice

§ Funding&financingforclinicalresearch

§ CommunityEngagement

National § Culture§ Politicalcontext/enablinglegislation§ Agendasettingandprioritization

§ Domesticfunding§ Regulation/regulatorycapabilities§ Coordination(incl.emergencyresponsecontexts)

§ Co-ordination

Macro(Intl.,Regional,Supranational)

§ Internationalrelationships(donors,fundersofresearch,south-south/northsouthcollaboration)§ Regionalandinternationalresearchnetworks§ Governance,accountabilityandsustainability

7.3 SUMMARYOFIVTFRECOMMENDATIONS

1 ByDecember2018,inordertoeffectivelyrespondtodiseaseoutbreaks,reducepreventable

deaths, strengthen productivity and improve quality of life, countries should commit to

strengtheningcapacity toconductorparticipate inclinical research toaddress theirpublic

healthneeds

2 Recognizing the existing IDA18 commitment to strengthen preparedness in at least 25

countries, theWorldBankGroupshould include,asapartof its IDAMid-Term (December

2018) Review (MTR), an investment framework for national and regional clinical research

capacities.

3 Byend2019,WHOshoulddevelopanddisseminateexamplesofbroadlyapplicablelegislation

andpoliciestosupportandenableefficientconductofclinicalresearch.Thisshouldinclude,

ataminimum,modelpoliciesandlawsthatsupporttheconductoftrials,enabletimelyethics

and regulatory review,address import/exportof relevant commoditiesandbio-specimens,

and address procurement and contracting systems. These policies should be a part of a

broadergovernancearchitectureforclinicalresearch.

4 By2019,ResearchForums/Institutionsand/orAcademiesofScienceinLMICs,drawingupon

theirexperienceandthatofothers,shouldsynthesizebestpracticesanddevelopguidancefor

considerationbycountriesonhowtobuildasupportiveresearchclimate/culture

5 Byend2018,WHOshouldconsolidatearobustsetofindicators,totheextentpossiblebuilding

on indicators already used by countries, develop a tool for assessment of country-level

capacitiesforclinicalresearch,andproposeaprocesstohelpcountriesrapidlyconductthese

assessments.

6 Byend2019,governmentsinIDA-eligiblecountriesshouldcommitshort-andmediumterm

resourcestoaddresstheirclinicalresearchcapacitygoals.Theseresourcescouldpotentially

comefromtheirIDAportfolios.

7 Byend2018,theWorldBankGroupshoulddevelopmechanismstobuydownIDAloansand

convert them into grants for countries that have demonstrated development of research

capacitybasedonagreedmilestones.

8 The World Bank Group should encourage IDA countries to establish or leverage existing

regionalpartnershipsfordevelopingclinicalresearchcapacity,usingtheIDARegionalWindow

funds combined with domestic commitments. The World Bank Group should highlight

progressandshowcasestrategicdevelopmentoutcomesofsuchregionalpartnershipsinthe

IDA18MTR(December2018),anddeveloparobustcaseforinclusionofprioritizedregional

clinicalresearchpartnershipsasathematicareaunderIDA19(January2020).

9 Byend2018,theWorldBankGroupshouldcollaboratewithdevelopmentpartnersandother

research funders to incentivize domestic resourcemobilization in developing countries for

investmentinclinicalresearchcapacity,includingbysuchmeansasmatchinggrantsandother

incentivizingmechanisms.

10 Bymid-2018,CEPI shouldcommit resources tostrengtheningclinical researchcapacities in

LMICs where clinical trials for vaccines against CEPI priority pathogens are likely to be

conducted.

11 By end 2019, the private sector pharmaceutical/ biotech industry/clinical research

organizations/ other health sector businesses operating in LMICs should announce their

commitment to maximize their contribution to clinical research capacity in LMICs. This

includestransferofskillsandexpertiseand/orallocatingapercentageof theirspendingto

supportthedevelopmentofclinicalresearchcapacity inLMICsthat isalignedwithcountry

publichealthneedsandnationalresearchagenda.

12 By end 2019, ESSENCE, in collaboration with the Global Coordination Mechanism and

reinforcedwithadditionalLMICrepresentation,shouldarticulateamechanismthatpermitsa

thoroughreviewofcurrentandplannedinvestmentsinresearchcapacitystrengthening.This

should be done in consultationwithmajor external funders of clinical research (including

those involved in capacity strengthening of network, laboratory, ethics, and regulatory

capability). This collaborative mechanism should ensure synergy at country and regional

levels, and streamline the administrative burden experienced by institutions dealing with

multipleresearchfunders.

13 By theendof2018, theWorldBankGroup,working through thePEFandCEPITrust Fund

mechanisms, should establish a rapid financing vehicle to support the priority outbreak-

relatedresearchagendaemergingfromtheWHOR&DBlueprint,andtostrengthenin-country

capacity,includingtheconductofclinicalresearchaspartofoutbreakresponse

14 By June 2019, based on experience accumulated by countries,WHO and theWorld Bank

Groupshoulddeveloparesourcetrackingtoolenablinggovernmentstomonitorandtrack,at

anationallevel,allfundingthatsupportsclinicalresearchcapacity-buildingactivitieswithin

thecountryandaccountsforthemultiplicityoffundersinvolved.

15 Reviewing progress on the implementation of these recommendations should inform the

agendaoftheGlobalPreparednessMonitoringBoard.

7.4 HIGHLEVELPROFILESOFSELECTEDRELEVANTMECHANISMS

High level profiles of selected mechanisms relevant to the coordination of investments in clinical

researchcapacitystrengthening/building

Followinganextensivereviewofexisting literatureonenhancingcollaboration,synergyand impactof

investmentsinclinicalresearchcapacitystrengthening,theunder-listedmechanismswereidentified.

1. TheSpecialProgrammeforResearchandTraininginTropicalDiseases–TDR

2. ESSENCE

3. WorldReport

4. TheGlobalObservatoryonHealthR&D

5. WHOClinicalTrialsRegistry

6. Clinicaltrials.gov–TheUSNationalLibraryofMedicine

7. ISRCTNRegistry

8. EUClinicalTrialRegister

9. PACTR

10. UKCDR11. PAHO12. WestAfricanHealthOrganization

13. EDCTP14. AMRCrossCouncilInitiative

15. JointProgrammingInitiativeonAntimicrobialResistance(JPIAMR)

16. GlobalAMRR&DHub

17. WestAfricanHealthOrganization

18. AsiaPacificObservatoryonHealthSystemsandPolicies(theAPO)

19. InstitutePasteur20. CoalitionforEpidemicPreparednessInnovations

21. AllianceforHealthPolicyandSystemsResearch(AHPSR)

22. CouncilonHealthResearchforDevelopment(COHRED)

23. TheCenreforIntegrationofDataandHealthKnowledge24. Intl.FederationofPharmaManufacturers&Associations

25. GlobalCoordinationMechanismonR&DBlueprint(GCM)

26. ProgramofR&DinHumanReproduction(HPR)

1. TheSpecialProgrammeforResearchandTraininginTropicalDiseases–TDR

Establishedin1975,theSpecialProgrammeforResearchandTraininginTropicalDiseases(TDR)ishosted

at the World Health Organization (WHO),and is sponsored by the United Nations Children’s Fund

(UNICEF),theUnitedNationsDevelopmentProgram(UNDP),theWorldBankandWHO.TDRisaglobal

programofscientificcollaborationthathelpsfacilitate,support,andinfluenceeffortstocombatdiseases

ofpoverty.46Since itsearliestdays,TDRhasbeencommitted to the two interdependentobjectivesof

supporting research to improve the control of infectious diseases, and strengthening the capacity of

disease-affectedcountriestoperformvaluablehealthresearchthemselves.47ThemissionoftheTDRis

“Tosupporteffectiveandinnovativeglobalhealthresearch,throughstrengtheningtheresearchcapacity

46https://www.who.int/tdr/about/en/

47TDRStrategy2018–2023:Buildingthescienceofsolutions

ofdisease-affectedcountries,andpromotingthetranslationofevidenceintointerventionsthatreduce

theburdenofinfectiousdiseasesandbuildresilienceinthemostvulnerablepopulations.”Formorethan

fortyyears,TDRhasbeenaleaderinresearchtoaddressinfectiousdiseasesofpoverty,andinbuilding

thecapacityof institutions, individualsandcommunities indisease-affectedcountries togenerate the

evidence and put in place the innovations needed to improve their health. TDR’s twin mission of

supporting researchand increasing researchcapacityhascreatednewtoolsandstrategies that led to

health improvements. Forexample,promotingbasic researchandproductdevelopmenton infectious

diseasesofpoverty,atatimewhenlittleofthisworkwassupported,paiddividendsinnewinterventions

that supported disease elimination campaigns. The TDR model which pioneered today’s product

developmentandpublic/privatepartnershipsresultedinadozennewdrugsforinfectiousdiseases.

2. TheWHOGlobalObservatoryonHealthR&D

TheGlobalObservatory onHealth R&D ‘theObservatory’ is a global-level initiative that aims to help

identifyhealthR&Dprioritiesbasedonpublichealthneeds,by:

§ consolidating, monitoring and analysing relevant information on the health R&D needs of

developingcountries;

§ buildingonexistingdatacollectionmechanisms;and

§ supportingcoordinatedactionsonhealthR&D.48

InvestmentsinhealthR&Darestillinsufficientlyalignedwithglobalpublichealthdemandsandneeds.As

littleas1%ofallfundingforhealthR&Disallocatedtodiseasessuchasmalariaandtuberculosis(diseases

thatarepredominantlyincidentindevelopingcountries),despitethesediseasesaccountingformorethan

12.5%oftheglobalburdenofdisease.TherecentoutbreakofEbolavirusdiseasedramaticallyexposed

thelackofinvestmentinproductsandapproachestopreventandminimizetheimpactofpathogenswith

epidemicpotential.Recently,thegapsinR&Dinvestmentsandthepipelineforantimicrobialmedicines

havealsobecomeacauseofglobalconcerninthecontextofrapidlyincreasingantimicrobialresistance.

Governments,policy-makers,fundersandresearchersthereforeneedanaccuratepictureofthecurrent

situationsoastospotR&Dgapsandensurethatfundsandresourcesareusedinthebestpossibleway.

In May 2013, the Sixty-sixth World Health Assembly specifically mandated the establishment of the

ObservatoryinresolutionWHA66.22,withtheoverallgoal“toconsolidate,monitorandanalyzerelevant

information on health research and development activities, … with a view to contributing to the

identificationandthedefinitionofgapsandopportunitiesforhealthresearchanddevelopmentpriorities,

andsupportingcoordinatedactionsonhealthresearchanddevelopment.”

TheSixty-ninthWorldHealthAssembly(May2016)re-emphasizedtheObservatory’scentralroleandthe

importanceofexpeditingitsdevelopment.InresolutionWHA69.23italsorequestedtheestablishment

of an expert committee on health R&D to set priorities for new investments based on information

primarilyprovidedbytheObservatory.

In addition, WHOMember States requested that the WHO Director-General ensure the R&D needs

relatingtothefollowingtwospecificareasofhealthconcern(wherecurrentmarketsandbusinessmodels

arefailing)aretrackedthroughtheObservatory:

48https://www.who.int/research-observatory/why_what_how/en/

§ antimicrobialresistanceandtheneedtodevelopnewmedicalproductstoprotectpopulations

fromtherisksoffailingtreatmentsagainstinfectiouspathogens(seeresolutionWHA67.25ofthe

Sixty-seventhWorldHealthAssemblyinMay2014);

§ a comprehensive R&D Blueprint preparedness plan that allows the rapid activation of R&D

activitiesduringfutureepidemics,suchastheepidemicthatoccurredduetoEbolavirusdisease.

(seeEB138/28ofthe138thsessionoftheWHOExecutiveBoard).

TheprimaryscopeoftheObservatoryasoutlinedbyMemberStatesinWorldHealthAssemblyresolution

WHA69.23is:

§ type II and type III diseases (i.e. diseases incident inboth rich andpoor countries, butwith a

substantialproportionofthecases inpoorcountries,anddiseasesthatareoverwhelminglyor

exclusivelyincidentindevelopingcountriesrespectively);

§ thespecificR&DneedsofdevelopingcountriesinrelationtotypeIdiseases(i.e.diseasesincident

inbothrichandpoorcountries,withlargenumbersofvulnerablepopulationsineach);

§ potentialareaswheremarketfailuresexist;

§ antimicrobialresistanceandonemerginginfectiousdiseaseslikelytocausemajorepidemics.

TheObservatorywillbeofusetogovernments,policy-makers,funders,researchersandcivilsociety,to:

reviewandqueryinformationoncurrenttrends,forexample,ininvestmentinhealthR&D,productsin

thepipelineandclinicaltrials;

§ look at comparisons of R&Dactivities between countries, diseases and in relation to relevant

informationsuchasburdenofdiseaseormacroeconomicindicators;

§ review global indicators on health R&D in the context of the Sustainable Development Goals

(SDGs);ormoregenerally

§ consultcomprehensivedisease-specificanalysesonidentifiedneedsandpriorities(whereset);

findrelevantkeypublications,databasesandresources;consulttheclassificationsandstandards

in use by the Observatory as a step towards galvanizing wider discussion and consensus to

harmonizeapproachestocollectandshareR&Ddata.

Since its inception, theGlobalObservatoryonHealthR&Dhas received funding support fromvarious

sourcestosupportitsestablishmentandexpansion,including:

§ EuropeanCommission

§ GovernmentofFrance

§ GovernmentofGermany

§ GovernmentofSwitzerland

§ GovernmentoftheUnitedStatesofAmerica

3. TheWorldReport

TheWorldRePORTishostedbytheUnitedStatesofAmerica’sNationalInstitutesofHealthandmanaged

throughasteeringcommitteeoftheagenciesprovidingdata.49Todate,theWorldRePORTincludesdata

reportedby12majorfundersofhealthresearch.Notallofthesefundersreportonayearlybasis.For

example,in2015only9ofthe12fundersreporteddata(forgrantsin2015).

49https://worldreport.nih.gov/app/#!/

Collectively,8ofthe12fundersthathavereportedsince2012makeupapproximately78%oftheannual

healthresearchexpendituresof55majorpublicandphilanthropicfundersofhealthresearchaccording

toViergever&Hendriks2015.The12majorfundersofhealthresearchare:

1. BillandMelindaGatesFoundationhttps://www.gatesfoundation.org/

2. CanadianInstitutesofHealthResearchhttp://www.cihr-irsc.gc.ca/e/193.html

3. EuropeanCommissionhttps://ec.europa.eu/commission/index_en

4. EuropeanandDevelopingCountriesClinicalTrialsPartnershiphttp://www.edctp.org/5. Institutnationalde lasantéetde larecherchemédicale(FrenchNational InstituteofHealthand

MedicalResearchhttps://www.inserm.fr/en

6. Max–Planck–Gesellschafthttps://www.mpg.de/11761628/profile-visions

7. MedicalResearchCouncilUK(MRC)https://mrc.ukri.org/

8. NationalInstitutesofHealth(NIH)https://www.nih.gov/9. InstitutPasteurhttps://www.pasteur.fr/en10. SIDA–SwedishInternationalDevelopmentCorporationAgencyhttps://www.sida.se/English/

11. SwedishResearchCouncilhttps://www.vr.se/english.html

12. Wellcomehttps://wellcome.ac.uk/

4. ESSENCE

ESSENCEonHealthResearchisaninitiativethatallowsdonorsandfunderstoidentifysynergies,bring

aboutcoherenceandincreasethevalueofresourcesandactionsforhealthresearch.Itsfocusisonlow-

andmiddle-incomecountries.50Overthepastseveraldecadesthevalueandimpactoffundingforhealth

researchhasbeengivenincreasing importance.Theresulthasbeenasharprise inuncoordinatedand

fragmented funding of an increased number of initiatives and projects. Recognizing that such

fragmentationandlackofcoordinationwastestimeandeffort,theESSENCEinitiativeaimstopromote

betterstrategiccooperationbetweenpartners,particularlyamongbilateraldevelopmentagenciesand

fundingorganizations.

ThegoalofESSENCEistoincreasetheimpactofsupportprovidedforresearchcapacitystrengtheningfor

healthinlow-andmiddle-incomecountries.

ESSENCEexecutesitsmandatebyundertakingthefollowingkeyactivities:

§ PolicyDialogue–Facilitatingenhancedpolicydialoguebetweenthefundersofresearchforhealth

toalignvoicesforstrongadvocacy.

§ Harmonization – Piloting a number of innovative approaches to achieve harmonization and

optimizationofresources,includingthedevelopmentofbestpracticeguidancedocuments.

§ Country Pilots – Promoting the development and implementation of national strategies for

researchandrelatedcountry-basedpilotmodelsofcollaborationbetweenprogrammes.

§ Evaluation – Improving methodologies, monitoring and evaluation indicators to track input,

process,outcomesandtheimpactofinvestmentincapacitydevelopment.

ESSENCEmembersincludesomeofthetopfundersofhealthresearcharoundtheworld–primarilyhealth

research funding agencies – and also international health institutions, government research agencies,

developmentagencies,philanthropistsandmultilateralinitiatives.ESSENCEonHealthResearchmembers

areadvisedbyaSteeringCommittee,whichpresentlyhassevenmembers,representingWellcomeTrust,

United Kingdom; Swedish International Development Cooperation Agency (SIDA), Sweden; Fogarty

50http://www.who.int/tdr/partnerships/initiatives/essence

International Center – National Institutes of Health, USA; Institut Pasteur, France; European and

Developing Countries Clinical Trials Partnership (EDCTP), Netherlands, United States Agency for

International Development (USAID); South African Medical Research Council (SAMRC), South Africa;

International Development Research Centre (IDRC), Canada; the Special Programme of Research,

DevelopmentandResearchTraininginHumanReproduction,WHO,Geneva;andtheSpecialProgramme

forResearchandTraininginTropicalDiseases(TDR)astheSecretariatoftheinitiative.

5. TheWHOInternationalClinicalTrialsRegistryPlatform(ICTRP)

TheestablishmentoftheICTRPfollowedtheMinisterialSummitonHealthResearchthattookplacein

MexicoCityinNovember2004whereparticipantscalledontheWHOtofacilitatetheestablishmentof:"anetworkofinternationalclinicaltrialsregisterstoensureasinglepointofaccessandtheunambiguousidentificationoftrials".Thiswasfurtherexpandedonduringthe58thWorldHealthAssemblyinResolution

WHA58.22thatcalledontheglobalscientificcommunity,internationalpartners,theprivatesector,civil

society,andotherrelevantstakeholdersto:"establishavoluntaryplatformtolinkclinicaltrialsregistersinorder toensurea singlepointofaccessand theunambiguous identificationof trialswithaview toenhancingaccesstoinformationbypatients,families,patientgroupsandothers"ThemainaimoftheWHOICTRPistofacilitatetheprospectiveregistrationoftheWHOTrialRegistration

DataSetonallclinicaltrials,andthepublicaccessibilityofthatinformation.51TheWHORegistryNetwork

providesprospectivetrialregistrieswithaforumtoexchangeinformationandworktogethertoestablish

bestpracticeforclinicaltrialregistration.

TheWHORegistryNetworkiscomposedof:

§ PrimaryRegistries

§ PartnerRegistries

§ DataProviders

§ RegistriesworkingwiththeICTRPtowardsbecomingPrimaryRegistries

WhichClinicalTrialRegistriescanbepartofTheWHORegistryNetwork?

Anyregistrythatentersclinicaltrialsintoitsdatabaseprospectively(thatis,beforethefirstparticipant

isrecruited),andmeetstheWHORegistryCriteriaorthatisworkingwithICTRPtowardsbecominga

PrimaryRegistrycanbepartoftheWHORegistryNetwork.

Primary Registries in theWHO Registry Network - Primary Registries in theWHO Registry Network

meetspecific criteriafor content, quality and validity, accessibility, unique identification, technical

capacityandadministration.PrimaryRegistriesmeettherequirementsoftheInternationalCommitteeof

MedicalJournalEditors(ICMJE).

Theregistriesthatcurrentlymeetthesecriteriaare:

1) AustralianNewZealandClinicalTrialsRegistry(ANZCTR)

2) BrazilianClinicalTrialsRegistry(ReBec)

3) ChineseClinicalTrialRegistry(ChiCTR)

4) ClinicalResearchInformationService(CRiS),RepublicofKorea

5) ClinicalTrialsRegistry-India(CTRI)

6) CubanPublicRegistryofClinicalTrials(RPCEC)

7) EUClinicalTrialsRegister(EU-CTR)

8) GermanClinicalTrialsRegister(DRKS)

9) IranianRegistryofClinicalTrials(IRCT)

51https://www.who.int/ictrp/about/en/

10) ISRCTN 11) JapanPrimaryRegistriesNetwork(JPRN)

12) ThaiClinicalTrialsRegistry(TCTR)13) TheNetherlandsNationalTrialRegister(NTR)14) PanAfricanClinicalTrialRegistry(PACTR)15) PeruvianClinicalTrialRegistry(REPEC)16) SriLankaClinicalTrialsRegistry(SLCTR)17)

PartnerRegistries–AllPartnerRegistriesmustalsobeaffiliatedwitheitheraPrimaryRegistryinthe

WHORegistryNetworkoranICMJEapprovedregistry.TheICTRPSecretariatisunabletoreceivedata

directly from Partner Registries. It is the responsibility of Primary Registries in the WHO Registry

NetworktoensurethattheirPartnerRegistriesmeetWHORegistryCriteria.

6. Clinicaltrials.gov–TheUSNationalLibraryofMedicine

ClinicalTrials.govisaresourceprovidedbytheU.S.NationalLibraryofMedicine.Itwascreatedasaresult

of the Food andDrug AdministrationModernization Act of 1997 (FDAMA). FDAMA required theU.S.

DepartmentofHealthandHumanServices (HHS), throughNIH, toestablisha registryof clinical trials

information for both federally and privately funded trials conducted under investigational new drug

applications to test theeffectivenessof experimental drugs for seriousor life-threateningdiseasesor

conditions.NIHandtheFoodandDrugAdministration(FDA)workedtogethertodevelopthesite,which

was made available to the public in February 2000.52ClinicalTrials.gov is a Web-based resource that

providespatients,theirfamilymembers,healthcareprofessionals,researchers,andthepublicwitheasy

accesstoinformationonpubliclyandprivatelysupportedclinicalstudiesonawiderangeofdiseasesand

conditions.TheWebsiteismaintainedbytheNationalLibraryofMedicine(NLM)attheNationalInstitutes

ofHealth (NIH). InformationonClinicalTrials.gov is provided andupdatedby the sponsoror principal

investigatoroftheclinicalstudy.StudiesaregenerallysubmittedtotheWebsite(thatis,registered)when

theybegin,andtheinformationonthesiteisupdatedthroughoutthestudy.Insomecases,resultsofthe

studyare submittedafter the studyends. ThisWeb site anddatabaseof clinical studies is commonly

referred to as a "registry and results database." ClinicalTrials.gov contains information aboutmedical

studiesinhumanvolunteers.MostoftherecordsonClinicalTrials.govdescribeclinicaltrials(alsocalled

interventional studies). A clinical trial is a research study inwhich human volunteers are assigned to

interventions(forexample,amedicalproduct,behavior,orprocedure)basedonaprotocol(orplan)and

arethenevaluatedforeffectsonbiomedicalorhealthoutcomes.ClinicalTrials.govalsocontainsrecords

describingobservationalstudiesandprogramsprovidingaccesstoinvestigationaldrugsoutsideofclinical

trials(expandedaccess).Studieslistedinthedatabaseareconductedinall50Statesandin207countries.

ClinicalTrials.govdoesnotcontaininformationaboutalltheclinicalstudiesconductedintheUnitedStates

becausenotallstudiesarerequiredbylawtoberegistered(forexample,observationalstudiesandtrials

thatdonotstudyadrug,biologic,ordevice).SeeFDAAA801andtheFinalRuleformoreinformation.

However, the rate of study registration has increased over time asmore policies and laws requiring

registrationhavebeenenactedandasmoresponsorsandinvestigatorshavevoluntarilyregisteredtheir

studies.

7. ISRCTNRegistry

52https://clinicaltrials.gov/ct2/about-site/background

TheISRCTNregistryisaprimaryclinicaltrialregistryrecognisedbyWHOandICMJEthatacceptsallclinical

researchstudies(whetherproposed,ongoingorcompleted),providingcontentvalidationandcuration

and theunique identificationnumbernecessary forpublication.All study records in thedatabaseare

freelyaccessibleandsearchable.ISRCTNsupportstransparencyinclinicalresearch,helpsreduceselective

reportingofresultsandensuresanunbiasedandcompleteevidencebase.53ISRCTNregistryissupported

by the Department of Health – UK, Medical Research Council – UK, Wellcome Trust and Canadian

InstitutesofHealthResearch.

8. EUClinicalTrialRegister

TheEUClinicalTrialsRegistercontainsinformationoninterventionalclinicaltrialsonmedicinesconducted

intheEuropeanUnion(EU),ortheEuropeanEconomicArea(EEA)whichstartedafter1May2004.Clinical

trialsconductedoutsidetheEU/EEAareincludedif:

§ theyformpartofaPaediatricInvestigationPlan(PIP),or:

§ theyaresponsoredbyamarketingauthorisationholder,andinvolvetheuseofamedicineinthe

paediatricpopulationaspartofanEUmarketingauthorisation.

The Register also provides information about older paediatric trials covered by an EU marketing

authorisation.TheRegisterenablesuserstosearchforinformationintheEudraCTdatabaseExternallink.

Thisisthedatabaseusedbynationalmedicinesregulatorsfordatarelatedtoclinicaltrialprotocols.The

dataon the resultsof these trials areentered into thedatabaseby the sponsors themselves andare

publishedinthisRegisteroncethesponsorshavevalidatedthedata.

The EU clinical trials register has been a primary registry in theWorld Health Organization (WHO's)

RegistryNetworksinceSeptember2011andisaWHORegistryNetworkdataprovider.Itisalsoavailable

ontheWHOInternationalClinicalTrialsRegistryPlatformExternallink.

9. PACTR

ThePACTRiscurrentlyfundedbytheEDCTPandmanagedbytheSouthAfricanCochraneCentre(SACC),

anintra-muralresearchunitoftheSouthAfricanMedicalResearchCouncil(MRC).TheSACCisfundedby

theMRCandthePACTRisfundedforthefollowingyearonano-costextensionbytheEDCTPtocomplete

itsdevelopmentphase.54TheregistryacceptsregistrationofclinicaltrialsfromallcountriesinAfrica.Itis

aprimaryregistryintheWHOICTRP.

10. UKCollaborativeonDevelopmentResearch(UKCDR)

TheUK Collaborative onDevelopment Research (UKCDR) is a group of government departments and

researchfundersworkingininternationaldevelopment.Foroveradecade,theUKCDRhasbroughtUK

research funders together to discuss priorities and coordinate efforts to garner maximum impact.

GovernedbytheStrategicCoherenceofODA-fundedResearch(SCOR)Board,themissionoftheUKCDR

is to “amplify the value and impact of research for global development by promoting coherence,

collaboration and joint action amongUK research funders”.55TheUKCDR anchors its strategy on the

followingoverlappingaims:

§ Acollectivevoicetoshapepolicy

§ Mapping,analysisandforesight

§ Conveningforcollaborationandjointaction

53http://www.isrctn.com/

54https://www.who.int/ictrp/network/pactr/en/

55https://www.ukcdr.org.uk/about-us/our-mission-and-strategy/

§ Sharinginformation,learningandbestpractice

ThecorecontributingmembersoftheUKCDRare:

§ DepartmentforInternationalDevelopment(DFID)

§ DepartmentforBusiness,EnergyandIndustrialStrategy(BEIS)

§ DepartmentforHealthandSocialCare(DHSC)

§ UKResearchandInnovation(UKRI)

§ WellcomeTrust

OthermembersoftheUKCDRincludetheForeignandCommonwealthOffice(FCO),theDepartmentfor

Environment, Food and Rural Affairs (DEFRA), the Government Office for Science and the devolved

governmentadministrationsintheUK.ThewiderstakeholdersincludetheUKandinternationalresearch

community,researchfundingdeliverypartners,andtheNGO,philanthropicandprivatesectors.

11. PanAmericanHealthOrganizationPAHO

EstablishedinDecember1902,PAHOisthespecializedinternationalhealthagencyfortheAmericas.With

27officesandthreespecializedcentersintheregion,PAHOpromotesevidence-baseddecision-making

to improve and promote health as a driver of sustainable development. It works with countries

throughouttheregiontoimproveandprotectpeople'shealth.PAHOengagesintechnicalcooperation

withitsmembercountriestofightcommunicableandnon-communicablediseasesandtheircauses,to

strengthenhealthsystems,andtorespondtoemergenciesanddisasters.PAHOiscommittedtoensuring

thatallpeoplehaveaccesstothehealthcaretheyneed,whentheyneedit,withqualityandwithoutfear

of falling intopoverty.Through itswork,PAHOpromotesandsupports the rightofeveryone togood

health.Toadvancethesegoals,PAHOpromotestechnicalcooperationbetweencountriesandworks in

partnershipwithministriesofhealthandothergovernmentagencies,civilsocietyorganizations,other

internationalagencies,universities,socialsecurityagencies,communitygroups,andotherpartners.PAHO

promotestheinclusionofhealthinallpublicpoliciesandtheengagementofallsectorsineffortstoensure

that people live longer, healthier lives, with good health as theirmost valuable resource. Under the

leadershipofits52membercountriesandterritories,PAHOsetsregionalhealthprioritiesandmobilizes

action to address health problems that respect no borders and that, in many cases, jeopardize the

sustainabilityofhealthsystems.56

PAHOwearstwoinstitutionalhats:itisthespecializedhealthagencyoftheInter-AmericanSystemand

alsoservesasRegionalOfficefortheAmericasoftheWorldHealthOrganization(WHO),thespecialized

healthagencyoftheUnitedNations.

12. European&DevelopingCountriesClinicalTrialsPartnership(EDCTP)

The European & Developing Countries Clinical Trials Partnership (EDCTP) was created in 2003 as a

European response to the global health crisis caused by the three main poverty-related infectious

diseases, HIV/AIDS, tuberculosis (TB) and malaria. Part of the European Commission’s Framework

Programmes, EDCTP brings together European Union (EU)Member States plus Norway, sub-Saharan

African countries, pharmaceutical companies, small and medium enterprises (SMEs), product

developmentpartnerships(PDPs)andinternationalfoundationstoadvancethedevelopmentofvaccines,

drugs, diagnostics and other interventions targeting poverty-related infectious diseases affecting sub-

SaharanAfrica57.

56https://www.paho.org/hq/index.php?option=com_content&view=article&id=91:about-paho&Itemid=220&lang=en

57http://www.edctp.org/web/app/uploads/2018/12/The-added-value-of-EDCTP-to-Africa.pdf

EDCTP’s mission is to accelerate the development of new or improved medicinal products for the

identification, treatment and prevention of infectious diseases, including emerging and re-emerging

diseases,throughpre-andpost-registrationclinicalstudies,withemphasisonphaseIIandIIIclinicaltrials.

EDCTP’sapproachintegratesconductofresearchwithdevelopmentofAfricanclinicalresearchcapacity

andnetworking58.TheaddedvalueofEDCTPinAfricaisevidentinmultiplewaysandatdifferentlevels–

- ContributingtotheachievementoftheAfricanUnion

- CreatingandretaininganewgenerationofAfricanscientists

- Strengtheningandharmonisingenablersofhigh-qualityandethicalclinicalresearch

- Contributingtotheprovisionofsafemedicalinterventions

- Promotingdemand-drivenresearch

- Bridgingthegapbetweenscienceandpolicyforhealth

- Promotingcross-borderengagementsacrossAfrica

- Ensuringtransparencyinclinicaltrialstoinformhealthresearch

- BoostingpreparednessforinfectiousdiseaseoutbreaksinAfrica

- SupportingintegratedcapacitybuildingforhealthresearchinAfrica

13. AMRFundersForum

TocoordinateandprioritisetheUK’sresearchresponsetotheUKAMR2013-2018strategy,theMedical

ResearchCouncil (MRC)established theUKAMRFunders Forum (AMRFF)59,whichbrings together21

researchfunders,includingtheUKResearchandInnovationcouncils,governmentdepartments,devolved

administrationsandcharities.AMRFFprovidesaforumforthesharingofinformationonactivitiesrelating

toAMR,andaframeworkforamorecoordinatedapproachtotacklingAMRresearchtomaximiseimpact

onnationalandinternationalpoliciesandactivities.TheForumhasidentifiedfourkeyresearchthemes

totargetinvestments.

14. AMRCrossCouncilInitiative

This inter-disciplinaryAMRcross-council initiative is focusedontheAMRFFfour themestosupporting

researchencompassingacademia,biopharma,diagnosticcompanies,veterinaryandthehealthservice.

Thecurrentfocusofthisinitiativeisonresistantbacteriaofhumansandanimals.Governanceisoverseen

byatop-levelSteeringGrouptoprovidescientificguidanceandensuredeliveryandanExecutiveGroup

of funding partners. Membership of the SteeringGroup includes experts that cross the remit of the

researchcouncils.EachthemehasitsownExpertScientificPaneltoassesstheresearchprogrammes.

15. JointProgrammingInitiativeonAntimicrobialResistance(JPIAMR)

JPIAMR is an international collaborative platform that coordinates national research funding,

multidimensionalAMRresearchandfundingonaglobalscaleandsupportscollaborativeactionforfilling

knowledgegapsonAMRwithaOneHealthperspective.Itbringstogether27-membernations.Ashared

58http://www.edctp.org/web/app/uploads/2018/09/Tackling-infectious-disease-in-sub-Saharan-Africa_EDCTP-funded-clinical-studies-for-

medical-interventions-2003-2018-4.pdf59AHRC,BBSRC,ChiefScientistOffice,Scotland(CSO),BEIS,DFID,DefenceScienceandTechnologyLaboratory(Dstl),DEFRA,DHSC,ESRC,

EPSRC,TheFoodStandardAgency(FSA),HealthandCareResearchWales,HSCR&DDivision,PublicHealthAgency,NorthernIreland,Innovate

UK,MRC,NERC,NationalInstituteofHealthResearch(NIHR),PublicHealthEngland(PHE),ScienceandTechnologyFacilitiesResearchCouncil

(STFC),VeterinaryMedicinesDirectorate(VMD),WellcomeTrust.

StrategicResearchAgendaoutlinesthekeyareastoaddressandprovidesguidanceforcountriestoalign

theirAMRresearchagendasnationallyandinternationally.Sinceitsinception,JPIAMRhasfundedmore

than50researchprojectsandnetworkswithjointfundsexceeding€65mtodate.

16. GlobalAMRR&DHub

AnewbodyannouncedatG202017tocoordinatethediscoveryanddevelopmentofurgentlyneeded

antimicrobialdrugs.TheGlobalAntimicrobialResistanceResearchandDevelopmentHub–GlobalAMR

R&DHubforshort–aimstofurtherimprovethecoordinationofinternationaleffortsandinitiativesto

tackleAMRwhilefurtherincreasinginvestmentsintoR&DforAMR.MembersareMinistriesofHealthand

membershipisopentobothG20andnon-G20statesandotherdonors.TheGermanFederalGovernment

hastakentheleadindrivingtheestablishmentoftheGlobalAMRR&DHub.Initially,thesecretariatof

theGlobalAMRR&DHubwillbebasedinBerlin,attheGermanCenterforInfectionResearch(DZIF).The

FederalMinistryofEducationandResearch(BMBF)willprovideupto500millioneurosoverthenextten

yearstowardsresearchtocombatantimicrobialresistance.Thehubwillworkwithexistingpartnerships,

suchasCARB-X.

17. WestAfricanHealthOrganization

TheWestAfricanHealthOrganization(WAHO)istheregionalAgencychargedwiththeresponsibilityof

safeguardingthehealthofthepeoplesinthesub-regionthroughtheinitiationandharmonizationofthe

policiesofMemberStates,poolingofresources,andcooperationwithoneanotherandwithothersfora

collectiveandstrategiccombatagainstthehealthproblemsofthesub-region.

Establishedin1987whentheHeadsofStateandGovernmentfromallfifteencountriesintheEconomic

CommunityofWestAfricanStates(ECOWAS)adoptedtheProtocolcreatingtheorganizationandeach

governmentsubsequentlyratified it,WAHOhastranscendedlinguisticbordersandhurdles inthesub-

region toserveall fifteenECOWASMemberStates.TheProtocol,grantsWAHOstatusasaSpecialized

AgencyofECOWASanddescribestheorganization’smissionas‘theattainmentofthehighestpossible

standardandprotection.’

Visionandstrategies:WAHOisaproactiveinstrumentofregionalhealthintegrationthatenableshigh-

impactandcost-effectiveinterventionsandprogramsby:

§ Maintainingsustainablepartnerships

§ Strengtheningcapacitybuilding

§ Collecting,interpretinganddisseminatinginformation

§ Promotingcooperationandensuringcoordinationandadvocacy

§ Exploitinginformationcommunicationtechnologies

WAHO has through its strategic programs, undertaken measures to combat Malaria, malnutrition,

HIV/AIDS,maternalandinfantmortality;preventionofblindnessactionsforeasyaccesstomedicinesand

vaccines,epidemiologicalsurveillanceaswellastrainingandhealthinformationmanagementinthesub-

region.Also,viaitssecondstrategicplan,WAHOisimplementingstrategicorientationssuchas;support

forqualityimprovementofthehealthsystemsofthesub-region,supportforhealthservicesimprovement

in the sub-region, support for development of sustainable financing of health and Institutional

developmentofWAHO.Thisisimplementedthroughvariousprograms.

18. AsiaPacificObservatoryonHealthSystemsandPolicies(theAPO)

APOisacollaborativepartnershipof interestedgovernments, internationalagencies,foundations,and

researchersthatpromotesevidence-informedhealthsystempolicyregionallyandinallcountriesinthe

AsiaPacificregion.

TheAPOcollaboratively identifiespriorityhealthsystemissuesacrosstheAsiaPacificregion,develops

andsynthesizesrelevantresearchtosupportandinformcountries’evidence-basedpolicydevelopment;

andbuildscountryandregionalhealthsystemsresearchandevidence-informedpolicycapacity.

TheAPO’smainfunctionsareto:

§ Establish a body of knowledge and evidence on health systems in the Asia Pacific region,

comparable across countries, through collection and analysis of information and research

evidenceonhealthcarepoliciesandreforms

§ Engage in in-country dialogue with key stakeholders, including government, development

partners, civil societyandacademia, to facilitatea sharedassessmentofeachhealth system's

strengthsandweaknessesthatbuildsconsensusonneededpolicydirectionsandhelpsdevelop

evidenceinformedhealthpolicieswithincountries

§ Develop and strengthen national and regional capacity in research, analysis and knowledge

translation

The members of APO include: Asian Development Bank, Department of Foreign Affairs and Trade,

Australia(DFAT),Fiji,HongKongSAR,RepublicofKorea,RepublicofthePhilippines,Singapore,SriLanka,

Thailand, World Bank, World Health Organization–Western Pacific RegionandSouth-East Asia

RegionOffices.

19. InstitutePasteur

TheInstitutPasteurisaprivate,non-profitfoundationthathasbeencontributingtothehistoryofscience,

medicineandpublichealthfor130years.Itsmissionistohelppreventandtreatdiseases,mainlythose

of infectious origin, through research, teaching, and public health initiatives. With an effective

managementpolicyandsuccessfulresponsestrategy,theManagement,BoardofDirectorsandGeneral

MeetingboardprovidetheimpetusfortheInstitutPasteur’sresearch.60Locatedin25countriesonfive

continents,theInstitutPasteurInternationalNetwork(RIIP)associates32institutions,whichareunited

bysharedvaluesandmissionsforthebenefitofpopulations.Itisauniquemodelforhealthcooperation

and,inadditiontoitsstructures,bringstogetherahumanandscientificcommunitythatfocusesonboth

localandinternationalhealthpriorities.Presentinnumerousendemicareas,theRIIPhas,timeandtime

again,demonstrateditsmajorroleasasentinelforemerginginfectiousdiseases.

20. CoalitionforEpidemicPreparednessInnovations(CEPI)

CEPI is an innovative global partnership between public, private, philanthropic, and civil society

organisationslaunchedinDavosin2017todevelopvaccinestostopfutureepidemics.CEPI’smissionisto

acceleratethedevelopmentofvaccinesagainstemerginginfectiousdiseasesandenableequitableaccess

tothesevaccinesforpeopleduringoutbreaks.61

Manyorganisationsoperatewithintheend-to-endspaceofvaccinefundingandR&Dimplementation.

However,anumberofcriticalgapshavebeenidentified,whichCEPIwasdesignedtofill.

60https://www.pasteur.fr/en/institut-pasteur

61https://cepi.net/

§ First, CEPI will advance vaccines against known threats through proof-of-concept and safety

testinginhumansandwillestablishinvestigationalvaccinestockpilesbeforeepidemicsbegin—

”justincase”.

§ Second,wewillfundnewandinnovativeplatformtechnologieswiththepotentialtoaccelerate

thedevelopmentandmanufactureofvaccinesagainstpreviouslyunknownpathogens(eg:within

16weeksfromidentificationofantigentoproductreleaseforclinicaltrials)—”justintime”.

§ Third,CEPIwillsupportandcoordinateactivitiestoimproveourcollectiveresponsetoepidemics,

strengthencapacityincountriesatrisk,andadvancetheregulatorysciencethatgovernsproduct

development.

21. AllianceforHealthPolicyandSystemsResearch(AHPSR)

Fortwodecades,theAllianceforHealthPolicyandSystemsResearch(theAlliance)hascontinuedtowork

toimprovethehealthofthoseinlow-andmiddle-incomecountriesbysupportingthegenerationanduse

ofevidencethatstrengthenshealthsystems.62AsaninternationalpartnershiphostedbytheWorldHealth

Organization,weAllianceworkstogetherwithorganizationsaroundtheworldto:

§ Provideauniqueforumforthehealthpolicyandsystemsresearchcommunity;

§ Supportinstitutionalcapacityfortheconductanduptakeofhealthpolicyandsystemsresearch;

§ Stimulate the generation of knowledge and innovations to nurture learning and resilience in

healthsystems;and

§ Increasethedemandforanduseofknowledgeforstrengtheninghealthsystems.

22. CouncilonHealthResearchforDevelopment(COHRED)

COHRED,theCouncilonHealthResearchforDevelopment,isaglobal,non-profitorganizationwhosegoal

istomaximizethepotentialofresearchandinnovationtodeliversustainablesolutionstothehealthand

developmentproblemsofpeoplelivinginlowandmiddle-incomecountries.63COHRED’svisionisthatall

low and low-middle income countries will have smarter and better resourced national research and

innovationsystemforhealthinplaceby2025–sotheycanconduct,partner,commissionoruseresearch

to address their own health priorities – take the lead in their own health, equity, socio-economic

developmentandbecomekeycontributorstoimprovingglobalhealth.

COHREDofferssolutionsinthreeways:

a. Technical Support – Expert analysis and support in research and innovation system analysis,

prioritysetting,performanceenhancement.COHREDalsoprovidesguidancetoinstitutionsand

governmentsonhowtonegotiatebetterresearchcontracts.

b. PracticalTools–RHInnOEthicsisaunique,cloud-basedresearchethicsmanagementsystem–

thatacceleratesandincreasesthequalityofethicsreviewofhealthresearch,potentiallyshaving

12monthsormoreofgettingproductstousers.

c. Global Action – Through its Global Forum on Research and Innovation for Health and the

Colloquium Series, COHRED provides a unique global platform to generate ideas, insights,

inspirationandintelligenceforitsconstituencies.

62https://www.who.int/alliance-hpsr/about/en/

63http://www.cohred.org/our-mission/

23. Intl.FederationofPharmaManufacturers&Associations

IFPMArepresentstheresearch-basedpharmaceuticalcompaniesandassociationsacrosstheglobe.The

research-basedpharmaceuticalindustry’s2millionemployeesresearch,developandprovidemedicines

andvaccinesthatimprovethelifeofpatientsworldwide.BasedinGeneva,IFPMAhasofficialrelations

with theUnitedNations and contributes industry expertise to help the global health community find

solutionsthatimproveglobalhealth.64

24. ProgramofR&DinHumanReproduction(HRP)

HRP is the main instrument within the United Nations system for research in human reproduction,

bringingtogetherpolicy-makers,scientists,healthcareproviders,clinicians,consumersandcommunity

representatives to identify and address priorities for research to improve sexual and reproductive

health.65

HRPsupportsandcoordinatesresearchonaglobalscale,synthesizesresearchthroughsystematicreviews

ofliterature,buildsresearchcapacityinlow-incomecountriesanddevelopsdisseminationtoolstomake

efficientuseofever-increasingresearchinformation.WHOisoneoffivecosponsorsofHRP,alongwith

UNDP,UNFPA,UNICEF,andtheWorldBank.Inaddition,theInternationalPlannedParenthoodFederation

(IPPF)andUNAIDSarebothmembersofHRP�sgoverningbody.

25. TheCenreforIntegrationofDataandHealthKnowledge(Cidacs)

CidacsispartoftheGonçaloMonizInstituteoftheOswaldoCruzFoundation,andthereforehasthesame

legal status. Cidacs is a complex of services, physical and human resources in integration with

interdisciplinary scientific projectsdevelopedbymultidisciplinary teams in the areasof epidemiology,

statistics,bioinformatics,andcomputing,amongotherspecialties.Itsmissionistocarryoutstudiesand

research, develop new investigative methodologies and promote professional and scientific training,

basedon interdisciplinaryprojects,basedonthe integrationof largedatabases(“bigdata”).Withthe

helpofavailableknowledgeandhigh-performancecomputingresourcesinsertedinasafeenvironment,

CIDACSwithitsactionwillcontributetotheproductionofinnovativeknowledgeinordertobroadenthe

understanding of the population’s health problems, as well as to support decision-making in public

policiesforthebenefitofsociety.66

Cidacswascreatedbydecree32-2016,linkedtotheboardofdirectorsofFiocruzBahia,withthefollowing

objectives:

a. Conduct studies and research, develop new investigative methodologies and promote

professional and scientific training, based on interdisciplinary projects and involving the

integrationoflargedatabases("bigdata");

b. Promote the integration of knowledge at different levels (population, individual and sub-

individual),withthepurposeofbroadeningthescopeofHealthSciences;

c. With thehelp of available knowledge andhigh-performance computing resources in a secure

environment, contribute to the production of innovative knowledge in order to broaden the

understanding of the population's health problems, as well as to support decision-making in

publicpolicies,forthebenefitofsociety;

64https://www.ifpma.org/

65https://www.who.int/life-course/partners/human-reproduction/en/

66https://cidacs.bahia.fiocruz.br/en/about/history/

d. Tomaintainanetworkofscientificinterdisciplinarycooperation,withnationalandinternational

partners, favoring and stimulating scientific and technological production in relevant and

innovativeaspectsforthehealthofthepopulationandfortheSUS.

26. GlobalCoordinationMechanismonR&DBlueprint(GCM)

On 28 March 2017, terms of reference for the Global Coordination Mechanism (GCM) for R&D

preparednesswerediscussedatitsfirstformalmeetinginLondon.TheprimaryroleoftheGCMistobuild

a consensual voluntary framework for key stakeholders to address global R&D challenges during

epidemics. The second objective is to provide a high-level discussion platform and enable sharing of

strategicdirections,nurturingcollaborationsand,addressingcrucialgaps,withoutduplicationofefforts.67

67https://www.who.int/blueprint/what/improving-coordination/global_coordination_mechanism/en/

7.5 APPROACHTODEVELOPINGTHEBACKGROUNDPAPER

7.6 METRICSFORASSESSINGNATIONALBIOMEDICALRESEARCHCAPACITY

Metricsfornationalbiomedicalresearchcapacity

DevelopedfortheWorldBankInternationalVaccinesTaskForce

January29,2018

Background:

TheWorldBankhasconvenedanInternationalTaskForceonStrengtheningCountryCapacityforVaccinesResearchandDevelopment (knowsas the InternationalVaccinesTaskForce [IVTF]) in response to theurgencyofstrengtheningbiomedicalresearchanddevelopment(R&D)capacityinlow-incomecountries

asacriticalsuccessfactorfortheCoalitionforEpidemicPreparednessandInnovation(CEPI).TheIVTFistasked with proposing ways national governments and development partners can effectively and

sustainablyestablishandfinancevaccineR&Dcapacityatthenationallevel.

Framework:

Followinginitialteleconferencesandaface-to-facemeetingonNovember10,2017,IVTFmemberssought

todevelopaframeworkandmetricsforbiomedicalR&Dwithafocusonclinicaltrialsincludingvaccine

trials. IVTFmembers further recommended that theGlobalHealthSecurityAgenda (GHSA)evaluation

systembeusedasatemplatesothatbiomedicalR&DcapacitymightbeevaluatedintheGHSAframework.

TheGHSAevaluation tool [68]use threecolorswitha totalof five levels (Table1).Thereare19GHSA

indicators;some,suchasnationallaboratorysystem,realtimesurveillance,andworkforcedevelopment,arerelevanttobiomedicalR&D,butGHSAcurrentlydoesnotincludeclinicaltrialscapacity,eitherinthe

countryevaluationsorasadevelopmentgoal.Eachofthe19GHSAindicatorsincludesfromonetofive

sub-indicators.

Table1.GHSAcolorscoringsystem

Score Color Description

1 Red Nocapacity Attributesofacapacityarenotinplace

2 Yellow Limitedcapacity Attributesofacapacityareindevelopmentstage(some

areachievedandsomeareundergoing;however,the

implementationhasstarted)

3 Yellow Developedcapacity Attributesofacapacityareinplace;however,thereis

theissueofsustainabilityandmeasuredbylackof

inclusionintheoperationalplaninNationalHealth

SectorPlanning(NHSP)and/orsecurefunding

4 Green Demonstratedcapacity Attributesareinplace,sustainableforafewmoreyears

andcanbemeasuredbytheinclusionofattributesor

IHR(2005)corecapacitiesinthenationalhealthsector

plan

68.https://www.ghsagenda.org/assessments#evaluations

5 Green Sustainablecapacity Attributesarefunctional,sustainableandthecountryis

supportingothercountriesinitsimplementation

Metrics:

Weexaminedthecurrentnumberofactiveclinicaltrialspercountryinsub-SaharanAfricaasa

benchmarktodevelopmetricsforclinicalresearchcapacity(Table2).Eighteencountrieshave0-5active

clinicaltrials,12countrieshave6-10trials,14have11-50trials,andsixcountrieshavemorethan50.

Additionalworkmaybecompletedtoexaminethesubsetsthatarerandomizedcontrolledclinicaltrials,

thoserelevanttodevelopmentofvaccinesandotherpandemiccountermeasures,trialsbyphase,and

trialsconductedunderconditionsofaninternationallicensingbodysuchastheEuropeanMedicines

AgencyortheU.S.FoodandDrugAdministration.

Table2.Numberofactiveclinicaltrialsinclinicaltrials.govbycountry,sub-SaharanAfrica–2017

CapeVerde 0

Comoros 0

Djibouti 0

Eritrea 0

Mauritania 0

SaoTome/Principe 0

Seychelles 0

Somalia 0

WesternSahara 0

Angola 1

CentralAfricanRep. 1

Chad 1

EquatorialGuinea 1

Madagascar 1

Namibia 1

Burundi 2

Réunion 2

Togo 4

Congo 6

Guinea 6

Mauritius 6

Niger 6

Swaziland 6

Lesotho 7

SierraLeone 7

Gambia 9

Guinea-Bissau 9

Liberia 9

Benin 10

Gabon 10

Sudan 12

Rwanda 14

Senegal 14

Côted'Ivoire 16

Botswana 17

Mozambique 17

Cameroon 19

DemRepofCongo 22

BurkinaFaso 23

Mali 27

Ghana 30

Ethiopia 33

Zimbabwe 35

Nigeria 48

Zambia 52

Malawi 63

Tanzania 65

Uganda 112

Kenya 114

SouthAfrica 549

Note:TobeupdatedwithresultsfromWHOInternationalClinicalTrialsRegistryPlatform(ICTRP)

http://www.who.int/ictrp/search/en/

Fromthisbenchmarkmetric,apreliminaryscoringsystemforclinicalresearchcapacitycanbe

developed(Table3).

Table3.Preliminaryscoringsystemfornationalclinicalresearchcapacity

Score Color Description Preliminaryproposedmetric

1 Red Nocapacity Littleornocapacitytoconductclinicalresearch;littleornonational

commitmenttodevelopcapacity

2 Yellow Limited

capacity

Limitedcapacitytoconductclinicalresearch;nationalinterestand

intentiontodevelopaconduciveenvironmentforclinicalresearch

3 Yellow Developed

capacity

Developedcapacitytoconductclinicalresearch,withlimited

domesticcapacitytoconductclinicaltrials,mainlywithexternal

support

4 Green Demonstrated

capacity

Demonstratedcapacitytoconductclinicalresearch,including

clinicaltrialsunderinternationallicensingconditions,mainlyunder

externalpartnerships

5 Green Sustainable

capacity

Sustainablecapacitytoconductclinicalresearchandclinicaltrials

underinternationallicensingconditionswithin-countrynationalsas

principalinvestigatorsanddirectfundingrecipients,supporting

othercountriesinimplementation

Asanadditional step, sub-indicatorscanbedevelopedto identify thecoreelements toguidecountry

biomedical researchcapacitybuilding.Severalpotential sub-indicatorsare listed inTable4.Additional

workby subjectmatterexperts isneeded to refineeachpotential sub-indicator.Additionalworkalso

needed to harmonize the framework, metrics, and sub-indicators with previous efforts to develop

organizationalandnationalmetricsofbiomedicalresearchcapacity[69,70].

Sixpotentialsub-indicatorsarelisted.TobeconsistentwithotherGHSAindicators,thenumberofsub-

indicators shouldbenomore than five.Theremaybeneed fora short listof<5 sub-indicators tobe

consistentwithGHSAandalongerlistformoredetailedassessmentsanddevelopmentofroadmapsfor

countrycapacitybuilding.

Regulatory:CriteriaandatoolhavebeendevelopedbytheWorldHealthOrganization(WHO)forNational

RegulatoryAuthoritiestoevaluatetheircompliancewiththefunctionsthey

mustfillasregulatorsofdrugsandbiologicalproducts[71].Percentageimplementationofindicatorsare

specifiedforeachlevel.

Good Clinical Practice: The International Council for Harmonisation of Technical Requirements for

Pharmaceuticals for Human Use (ICH) brings together regulatory authorities and the pharmaceutical

industry todiscuss scientific and technical aspectsofdrug registration.The ICHGoodClinicalPractice

69.Planning,monitoringandevaluationframeworkforresearchcapacitystrengthening(2016)byESSENCEonHealthResearch.

http://www.who.int/tdr/publications/Essence_frwk_2016_web.pdf70.KirigiaJM,OtaMO,SenkubugeF,WiysongeCS,MayosiBM.DevelopingtheAfricannationalhealthresearchsystemsbarometer.HealthRes

PolicySyst.2016Jul22;14(1):53.71.PAHO/WHO.SystemforEvaluationoftheNationalRegulatoryAuthoritiesforMedicines,Standarizedevaluationprocedure(2010)

http://www1.paho.org/hq/dmdocuments/2010/POS-EvaluacioRES1.pdf

(GCP)Guideline,lastamendedin2016,describestheresponsibilitiesandexpectationsofallparticipants

intheconductofclinicaltrials,includinginvestigators,monitors,sponsorsandIRBs[72].

Laboratory:Curriculaandchecklistshavebeenpromulgatedtodevelopandassesslaboratorycapacity

forclinicaltrials(GoodClinicalLaboratoryPractice[GCLP])[73,74].

Community participation: International standards for community participation (Good Participatory

Practice[GPP])inbiomedicalresearchhavebeenestablishedforHIV[75]andforemerginginfections[

76].

Datamanagement:TheinternationalSocietyforClinicalDataManagementhasdevelopedguidelinesfor

GoodClinicalDataManagementPractices(GCDMP)[77].

72.InternationalCouncilforHarmonisationofTechnicalRequirementsforPharmaceuticalsforHumanUse.EfficacyGuidelines:GoodClinical

Practice(2016).http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html73.WorldHealthOrganization,SpecialProgrammeforResearchandTraininginTropicalDiseases(2009).Goodclinicallaboratorypractice

(GCLP).Availableat:http://www.who.int/tdr/publications/documents/gclp-web.pdf74.NationalInstituteofAllergyandInfectiousDiseases(2013).DAIDSGuidelinesforGoodClinicalLaboratoryPracticeStandards.Availableat:

https://www.niaid.nih.gov/sites/default/files/gclp.pdf75.UNAIDS/WHO.EthicalconsiderationsinbiomedicalHIVpreventiontrials.Geneva,2012.Availableat:

http://files.unaids.org/en/media/unaids/contentassets/documents/unaidspublication/2012/jc1399_ethical_considerations_en.pdf76.WorldHealthOrganization.Goodparticipatorypracticeguidelinesfortrialsofemerging(andre-emerging)pathogensthatarelikelytocause

severeoutbreaksinthenearfutureandforwhichfewornomedicalcountermeasuresexist(GPP-EP).WHOPress,Geneva;2016.Availableat:

http://www.who.int/blueprint/what/norms-standards/GPP-EPP-December2016.pdf?ua=177.SocietyforClinicalDataManagement.GoodClinicalDataManagementPractices(GCDMP),2013.Availableat:

https://www.scdm.org/publications/gcdmp/

Table4.Preliminarysub-indicatorscoringsystemfornationalclinicalresearchcapacity

NRA=NationalRegulatoryAuthority,PI=principalinvestigator,CT=clinicaltrial,GCP=goodclinicalpractice,GCLP=goodlaboratorypractice,GCDMP=goodclinicaldatamanagementpractice,GPP=goodparticipatorypractice

Score Color Description Potentialsub-indicatorsEthicalreview

Regulatory71 Humanresources72

Laboratory73,74 Datamanagement77

Communityparticipation75,76

1 Red Nocapacity [TBDfromWHO]

Doesnotmeetcertaindrughealthregulationfunctions

Noclinicalresearchsites

Nolaboratoriesconductingclinicalresearch

Noclinicalresearchdatamanagement

Noclinicalresearchwithcommunityparticipation

2 Yellow Limitedcapacity “

Meetscertaindrughealthregulationfunctions

>1clinicalresearchsite

>1laboratoryconductingclinicalresearch

>1sitemanagingclinicalresearchdata

>1siteconductingclinicalresearchwithcommunityparticipation

3 Yellow Developedcapacity

“

NRAperformscertainWHO-recommendedfunctions

>1siteconductingclinicalresearchtoGCPstandards

>1siteconductingclinicalresearchtoGCLPstandards

>1siteconductingclinicalresearchtoGCDMPstandards

>1siteconductingclinicalresearchtoGPPstandards

4 Green Demonstratedcapacity

“

NRAimprovingperformanceofcertainWHO-recommendedfunctions

>2sitesconductingCTforintl.licensingtoGCPstandards

>2laboratoriesconductingCTforintl.licensingtoGCLPstandards

>2sitesconductingCTforintl.licensingtoGCDMPstandards

>2sitesconductingCTtoGPPstandardsandcommunityparticipationresearchwithnationalco-investigators

5 Green Sustainablecapacity–withnationalssupportingothercountries’implementationineacharea

“

NRAperformsWHO-recommendedfunctions

>2sitesconductingCTforintl.licensingtoGCPstandardswithnationalPIs

>2laboratorieswithnationalleadershipconductingCTforintl.licensingtoGCLPstandards

>2siteswithnationalleadershipconductingCTdataforintl.licensingtoGCDMPstandards

>2sitesconductingCTtoGPPstandardsandcommunityparticipationresearchwithnationalPIs

Documents

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