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Registration of Clinical Trials:Registration of Clinical Trials:Background and ImplementationBackground and Implementation
Ida Sim, MD, PhDIda Sim, MD, PhD
Project CoordinatorProject Coordinator
Department of Research Policy and CooperationDepartment of Research Policy and Cooperation
World Health OrganizationWorld Health Organization
Geneva, Switzerland;Geneva, Switzerland;
and University of California San Francisco, USAand University of California San Francisco, USA
August 22, 2006August 22, 2006
Ida Sim, WHO, 2006
OutlineOutline
BackgroundBackground Why register trials?Why register trials?
Why WHO project?Why WHO project?
WHO International Clinical Trials Registry PlatformWHO International Clinical Trials Registry Platform
Intellectual Property ConcernsIntellectual Property Concerns
Current WorkCurrent Work
SummarySummary
Ida Sim, WHO, 2006
Clinical TrialsClinical Trials
Everyone wants to do evidence-based medicineEveryone wants to do evidence-based medicine health care delivery based on best available health care delivery based on best available
evidenceevidence
Clinical trials one of the most valuable sources of Clinical trials one of the most valuable sources of evidence about evidence about
whether a health treatments workswhether a health treatments works whether it is safewhether it is safe
Billions of dollars spent worldwide every year on Billions of dollars spent worldwide every year on clinical trialsclinical trials
Critical that public trusts clinical trial resultsCritical that public trusts clinical trial results
Ida Sim, WHO, 2006
Can We Trust Clinical Trials?Can We Trust Clinical Trials?
““Publication bias”: negative results often not published Publication bias”: negative results often not published small, negative studies least likely to be publishedsmall, negative studies least likely to be published negative studies often not submitted to journalsnegative studies often not submitted to journals only ~40% of meeting abstracts published only ~40% of meeting abstracts published (Scherer, 94)(Scherer, 94)
of trials submitted to FDA in support of drugs that of trials submitted to FDA in support of drugs that were eventually approved were eventually approved (Sim, in prep)(Sim, in prep)
only 42% published in 3.7 years after drug approved only 42% published in 3.7 years after drug approved negative trials less likely to be publishednegative trials less likely to be published
Publication bias can mislead clinical practicePublication bias can mislead clinical practice combination chemo for ovarian cancer combination chemo for ovarian cancer (Simes, 86)(Simes, 86)
p = 0.02 in published trialsp = 0.02 in published trials p = 0.25 in all registered trialsp = 0.25 in all registered trials
Ida Sim, WHO, 2006
Can We Trust Clinical Trials? (cont.)Can We Trust Clinical Trials? (cont.)
CLASS trial published in JAMA, 2001CLASS trial published in JAMA, 2001 6 month data showed celecoxib caused fewer 6 month data showed celecoxib caused fewer
symptomatic ulcers and ulcer complications symptomatic ulcers and ulcer complications than did diclofenac or ibuprofenthan did diclofenac or ibuprofen
but trial protocol included 12 month timepoint, but trial protocol included 12 month timepoint, which did not show any differenceswhich did not show any differences
Outcomes reporting bias Outcomes reporting bias (Chan, 2004)(Chan, 2004)
comparing ethics board protocols to comparing ethics board protocols to publications, 50% of efficacy outcomes not publications, 50% of efficacy outcomes not reportedreported
positive outcomes more likely to be reported positive outcomes more likely to be reported (O.R. 2.4, 95% c.i. 1.4-4.0)(O.R. 2.4, 95% c.i. 1.4-4.0)
Ida Sim, WHO, 2006
What to Do?What to Do?
Problem generally known for over 30 yearsProblem generally known for over 30 years
Solution is to Solution is to registerregister all trials before they all trials before they startstart
collect key scientific parameters (e.g., collect key scientific parameters (e.g., outcomes and timepoints) outcomes and timepoints)
allows tracking of trials to ensure that all allows tracking of trials to ensure that all trials and all results are publishedtrials and all results are published
But nothing happened until...But nothing happened until...
Ida Sim, WHO, 2006
Extensive Media CoverageExtensive Media Coverage
Aug 2004Aug 2004 GSK settles US$20 million suit for fraud in not GSK settles US$20 million suit for fraud in not
reporting negative paroxetine resultsreporting negative paroxetine results
Sept 2004Sept 2004 Merck pulled rofecoxib off the market amid Merck pulled rofecoxib off the market amid
continuing concerns that data was hidden from continuing concerns that data was hidden from publicpublic
estimated tens of thousands of heart attacks estimated tens of thousands of heart attacks happened unnecessarilyhappened unnecessarily
Ida Sim, WHO, 2006
Need for Trial RegistrationNeed for Trial Registration
Public needs and deserves a full and unbiased Public needs and deserves a full and unbiased public record on safety and effectivenesspublic record on safety and effectiveness
Trial registration is necessary to ensure full Trial registration is necessary to ensure full reporting of trial resultsreporting of trial results
Global need to restore public trust in clinical Global need to restore public trust in clinical trials, avoid drop in participant enrollmenttrials, avoid drop in participant enrollment
Ida Sim, WHO, 2006
OutlineOutline
BackgroundBackground Why register trials?Why register trials?
Why WHO project?Why WHO project?
WHO International Clinical Trials Registry PlatformWHO International Clinical Trials Registry Platform
Intellectual Property ConcernsIntellectual Property Concerns
Current WorkCurrent Work
SummarySummary
Ida Sim, WHO, 2006
Current PoliciesCurrent Policies
As of September 2005, International Committee As of September 2005, International Committee of Medical Journal Editors (ICMJE) journals accept of Medical Journal Editors (ICMJE) journals accept only registered trials for potential publicationonly registered trials for potential publication
many other journals have followed this policymany other journals have followed this policy
Many trial registration laws and policies being Many trial registration laws and policies being proposed worldwideproposed worldwide
e.g., ~50 laws proposed or adopted in US states e.g., ~50 laws proposed or adopted in US states and Congressand Congress
Overlapping and conflicting laws will make multi-Overlapping and conflicting laws will make multi-country trials difficultcountry trials difficult
Ida Sim, WHO, 2006
Many Registers WorldwideMany Registers Worldwide
Probably around 1000 registers exist worldwideProbably around 1000 registers exist worldwide
Registers vary in their Registers vary in their scope: e.g., country, disease, funderscope: e.g., country, disease, funder
many new country registers (many new country registers (India, China, South Africa, India, China, South Africa, Germany, Iran, etc.)Germany, Iran, etc.)
purpose: e.g., participant enrollment, administrative purpose: e.g., participant enrollment, administrative tracking, scientific analysis tracking, scientific analysis
Need for global standardization, coordination, and cooperationNeed for global standardization, coordination, and cooperation
Ida Sim, WHO, 2006
Why World Health Organization?Why World Health Organization?
Global, neutral, independent body with convening Global, neutral, independent body with convening capacity capacity (i.e. World Health Assembly resolutions)(i.e. World Health Assembly resolutions)
Authoritative; Role in setting norms and Authoritative; Role in setting norms and standards in research, standards in research, policy and practicepolicy and practice
Good Clinical Practice, Ethics guidelines, Good Clinical Practice, Ethics guidelines, Classification standards Classification standards (e.g., ICD)(e.g., ICD)
Contributes to capacity building Contributes to capacity building (i.e. in developing countries)(i.e. in developing countries)
Political legitimacy, accountable to 192 member Political legitimacy, accountable to 192 member StatesStates
Commitment to achieving equity in healthCommitment to achieving equity in health
Ida Sim, WHO, 2006
Leading up to WHO Registry PlatformLeading up to WHO Registry Platform
Oct 2003Oct 2003
WHO Director-General highlighted trial WHO Director-General highlighted trial registration in global health researchregistration in global health research
Oct 2004Oct 2004 –Rockefeller Foundation meeting, NY –Rockefeller Foundation meeting, NY
Need for global approach to trial registrationNeed for global approach to trial registration
WHO should establish formal process on a global WHO should establish formal process on a global approachapproach
Ida Sim, WHO, 2006
Leading up to Leading up to WHO Registry PlatformWHO Registry Platform
Nov 2004Nov 2004 – Ministerial Summit on Health Research, – Ministerial Summit on Health Research, Mexico CityMexico City
Ministers of Health and others from 52 countries called on WHO to • establish network of clinical trial registers • ensure unambiguous identification of trials• ensure a single point of access
April 2005April 2005 – Technical Consultation, Geneva – Technical Consultation, Geneva Meeting of diverse stakeholders to build consensus Meeting of diverse stakeholders to build consensus
policiespolicies
May 2005May 2005 – 58 – 58th th World Health AssemblyWorld Health Assembly
Ida Sim, WHO, 2006
"We are ready to move
forward with an
international Clinical Trials
Registry. This will do much
to strengthen the research
process and its ability to win
public trust"
"We are ready to move
forward with an
international Clinical Trials
Registry. This will do much
to strengthen the research
process and its ability to win
public trust"
Dr J.W. Leepast WHO Director-General
Opening Address to World Health Opening Address to World Health Assembly, May 2005Assembly, May 2005
Ida Sim, WHO, 2006
WHO Registry PlatformWHO Registry Platform Registry Platform project is now a global leader in trial Registry Platform project is now a global leader in trial registrationregistration
havehave received support and participation from all relevant stakeholder groups
Accomplishments to date defined 20 item WHO Trial Registration Data Set
called for full disclosure of registration data at time of registration (no “lockbox”)
outlined a coordinated global platform for trial registration
But much more needs to be done to make trial registration a widespread and routine reality
Ida Sim, WHO, 2006
OutlineOutline
BackgroundBackground Why register trials?Why register trials?
Why WHO project?Why WHO project?
WHO International Clinical Trials Registry PlatformWHO International Clinical Trials Registry Platform
Intellectual Property ConcernsIntellectual Property Concerns
Current WorkCurrent Work
SummarySummary
Ida Sim, WHO, 2006
Goal and Goal and ObjectivesObjectives
Goal strengthen public trust in clinical research by promoting
transparency and accountability
Objectives ensure that all interventional trials worldwide are
registered and thus publicly declared and identifiable ensure that a minimum set of results are publicly reported
for all registered trials develop compliance mechanisms to ensure that all parties
follow the same rules support use of trial registration information for recruitment,
research planning, etc.
Ida Sim, WHO, 2006
Registry Platform Registry Platform Administrative StructureAdministrative Structure
International Advisory Board
broad-based, 15 senior leaders
advise on strategy/direction
lead in communication/ advocacy
Scientific Advisory Group 21 experts advise on principles/
substantive standards working groups
trial registers results reporting
Registry Platform
Secretariat
WHO EIP/RPC
Scientific Advisory Group
InternationalAdvisory Board
Ida Sim, WHO, 2006
FundingFunding
Internal SupportInternal Support
WHO start-up and operational fundsWHO start-up and operational funds
External SupportExternal Support
English Department of HealthEnglish Department of Health Japanese Ministry of HealthJapanese Ministry of Health Wellcome TrustWellcome Trust Canadian Institutes of Health ResearchCanadian Institutes of Health Research
In-kind support from experts and stakeholdersIn-kind support from experts and stakeholders
Travel, meetings, consultationsTravel, meetings, consultations
Ida Sim, WHO, 2006
Registry PlatformRegistry Platform Overview Overview
WH
O I
nte
rnati
on
al C
lin
ical
Tri
als
Reg
istr
y P
latf
orm
Journals
ResultsDatabases
WHO Search Portal
RegistriesISRCTNct.gov . . .country specific
Ida Sim, WHO, 2006
Which Trials Must RegisterWhich Trials Must RegisterThe registration of all interventional trials is a scientific, The registration of all interventional trials is a scientific, ethical, and moral responsibilityethical, and moral responsibility
Any research studyAny research study that prospectively assigns humans that prospectively assigns humans or or groups of humans to one or more health related groups of humans to one or more health related interventions to evaluate the effects on health outcomes interventions to evaluate the effects on health outcomes IncludesIncludes
all health interventions (e.g., drugs, devices, cells and all health interventions (e.g., drugs, devices, cells and biological products, procedures, behavioral treatments, biological products, procedures, behavioral treatments, care process changes, etc) care process changes, etc)
early and late phase studiesearly and late phase studies
studies on healthy volunteersstudies on healthy volunteers
marketed and not-yet-approved products and indicationsmarketed and not-yet-approved products and indications
randomized and non-randomized, etc.randomized and non-randomized, etc.
Responsible Registrant
GlobalDeduplication
WHO Search Database
WHO Central Reference Database
1
5
6
WHO Registration Data Set4
8
2
MeSH Coding
3
7
UTRN, MeSH Codes
Associate Registers
Primary Registers
Other Registers
Search Portal
Ida Sim, WHO, 2006
Responsible RegistrantResponsible RegistrantEither the principal investigator (PI) or the primary sponsor, to be decided between them
primary sponsor is “the individual, organization, group or other legal person taking on responsibility for securing the arrangements to initiate and/or manage a study”
primary sponsor is ultimately responsible for ensuring that the trial is properly registered
for multi-centre and multi-sponsor trials, lead PI or lead sponsor is responsible registrant
Should make every reasonable effort to ensure that a trial is registered
only once in any register
registered in the fewest number of registers necessary to meet relevent regulations
Responsible Registrant
GlobalDeduplication
WHO Search Database
WHO Central Reference Database
1
5
6
WHO Registration Data Set4
8
2
MeSH Coding
3
7
UTRN, MeSH Codes
Associate Registers
Primary Registers
Other Registers
Search Portal
Ida Sim, WHO, 2006
Register Network StructureRegister Network Structure
Two-tiered systemTwo-tiered system Primary Registers (relatively few)Primary Registers (relatively few)
should be national, regional, or international should be national, regional, or international maximum of one per countrymaximum of one per country
submit Registration Data Set directly to WHOsubmit Registration Data Set directly to WHO
Associate Registers (relatively many) Associate Registers (relatively many) serve diverse constituents and objectives serve diverse constituents and objectives must be affiliated with a Primary Registermust be affiliated with a Primary Register
submit Registration Data Set to that registersubmit Registration Data Set to that register
Ida Sim, WHO, 2006
Draft Primary Register CriteriaDraft Primary Register Criteria
Main requirementsMain requirements perform quality assurance and local deduplicationperform quality assurance and local deduplication use Registry Platform data interchange standard use Registry Platform data interchange standard entries can be in any language, but uploads to WHO entries can be in any language, but uploads to WHO
must be in Englishmust be in English open access (free public access to all entries) open access (free public access to all entries)
Encouraged but not required toEncouraged but not required to
Collect or store protocol document itselfCollect or store protocol document itself Collect or store protocol amendmentsCollect or store protocol amendments Store or link to trial resultsStore or link to trial results
Should charge no or only minimal registration fees Should charge no or only minimal registration fees
Ida Sim, WHO, 2006
Registers and Registers and Global Regulatory CapacityGlobal Regulatory Capacity
Want the fewest number of registers necessary to Want the fewest number of registers necessary to serve global needsserve global needs
easier to identify duplicates and assign UTRNeasier to identify duplicates and assign UTRN WHO working with countries to coordinate regional WHO working with countries to coordinate regional approaches to trial registrationapproaches to trial registration
Latin America leading in establishing a regional Latin America leading in establishing a regional approachapproach
Trial registers may be focal points for developing Trial registers may be focal points for developing clinical trial regulatory capacityclinical trial regulatory capacity
national and regional registers listing ongoing trials national and regional registers listing ongoing trials
link to ethics review mechanisms, GCP, etc.link to ethics review mechanisms, GCP, etc.
Responsible Registrant
GlobalDeduplication
WHO Search Database
WHO Central Reference Database
1
5
6
WHO Registration Data Set4
8
2
MeSH Coding
3
7
UTRN, MeSH Codes
Associate Registers
Primary Registers
Other Registers
Search Portal
Ida Sim, WHO, 2006
WHO Registration Data Set (1)WHO Registration Data Set (1)
1.1. Primary Register and Trial ID# (e.g., NCT)Primary Register and Trial ID# (e.g., NCT)
2.2. Date of Registration in Primary RegisterDate of Registration in Primary Register
3.3. Secondary ID#sSecondary ID#s
4.4. Source(s) of Monetary or Material SupportSource(s) of Monetary or Material Support
5.5. Primary SponsorPrimary Sponsor
6.6. Secondary Sponsor(s)Secondary Sponsor(s)
7.7. Contact for Public QueriesContact for Public Queries
8.8. Contact for Scientific QueriesContact for Scientific Queries
9.9. Public TitlePublic Title
10.10. Scientific TitleScientific Title
Ida Sim, WHO, 2006
WHO Registration Data Set (2)WHO Registration Data Set (2)
11.11. Countries of RecruitmentCountries of Recruitment
12.12. Health Condition(s) or Problem(s) StudiedHealth Condition(s) or Problem(s) Studied
13.13. Intervention(s)Intervention(s)
14.14. Key Inclusion & Exclusion CriteriaKey Inclusion & Exclusion Criteria
15.15. Study TypeStudy Type
16.16. Date of First EnrollmentDate of First Enrollment
17.17. Target Sample SizeTarget Sample Size
18.18. Recruitment StatusRecruitment Status
19.19. Primary Outcome(s)Primary Outcome(s)
20.20. Key Secondary Outcome(s)Key Secondary Outcome(s)
Responsible Registrant
GlobalDeduplication
WHO Search Database
WHO Central Reference Database
1
5
6
WHO Registration Data Set4
8
2
MeSH Coding
3
7
UTRN, MeSH Codes
Associate Registers
Primary Registers
Other Registers
Search Portal
Ida Sim, WHO, 2006
Local and Global DeduplicationLocal and Global Deduplication
Trials may be registered in more than one register (e.g., to meet laws, to increase enrollment)
Registering a trial several times can make it look like there is more research going on than there really is
Need to deduplicate trial registrations Local deduplication
individual registers should identify duplicate entries within their own register
Global deduplication WHO will coordinate the identification of duplicates
across registers worldwide
Ida Sim, WHO, 2006
Universal Trial Reference Number Universal Trial Reference Number (UTRN)(UTRN)New number to be issued by WHO to each trial deemed New number to be issued by WHO to each trial deemed unique across registersunique across registers
unique trial: conducted according to a single document (the protocol) that describes the trial’s objective(s), design, methods, statistical considerations, and organization
multi-center trial: conducted according to a single protocol but carried out at more than one site
UTRN will cross-reference entries for same trial across UTRN will cross-reference entries for same trial across multiple registersmultiple registers
each single, unique trial will have one UTRNeach single, unique trial will have one UTRN each UTRN will relate to a single unique trial worldwideeach UTRN will relate to a single unique trial worldwide no current trial ID number performs this functionno current trial ID number performs this function promotes integrity of entire systempromotes integrity of entire system
Responsible Registrant
GlobalDeduplication
WHO Search Database
WHO Central Reference Database
1
5
6
WHO Registration Data Set4
8
2
MeSH Coding
3
7
UTRN, MeSH Codes
Associate Registers
Primary Registers
Other Registers
Search Portal
Ida Sim, WHO, 2006
Search Portal and Interchange Search Portal and Interchange StandardsStandards
Search Portal will search all Primary RegistersSearch Portal will search all Primary Registers provides gateway to trial information worldwideprovides gateway to trial information worldwide wwill have patient and scientist versionsill have patient and scientist versions
Data interchange standard in early testing phaseData interchange standard in early testing phase an XML standard for Registration Data Set an XML standard for Registration Data Set
interchangeinterchange developed with CDISC, industry clinical trial data developed with CDISC, industry clinical trial data
standardsstandards associationassociation
Ida Sim, WHO, 2006
Registry PlatformRegistry Platform Overview Overview
RegistersISRCTNCT.gov . . .country specific
WH
O I
nte
rnati
on
al C
lin
ical
Tri
als
Reg
istr
y P
latf
orm
Journals
ResultsDatabases
WHO Search Portal
Ida Sim, WHO, 2006
OutlineOutline
BackgroundBackground Why register trials?Why register trials?
Why WHO project?Why WHO project?
WHO International Clinical Trials Registry PlatformWHO International Clinical Trials Registry Platform
Intellectual Property ConcernsIntellectual Property Concerns
Current WorkCurrent Work
SummarySummary
Ida Sim, WHO, 2006
““Intelletual Property” ConcernsIntelletual Property” Concerns
Key scientific features of trials intervention, outcomes, condition, and sample size
Revealing this information publicly at start of enrollment may allow competitors unfair advantage
a competitive advantage issue
To protect competitive advantage, pharma industry (IFPMA, PhRMA) proposed
storing registration data privately with 3rd party data to revealed to the public
only for products that receive marketing approval
within 1 year of product approval in any country if safety concerns, at discretion of company
Ida Sim, WHO, 2006
Issue is Timing of DisclosureIssue is Timing of Disclosure
Issue was not Issue was not whetherwhether to register, but when should to register, but when should data be made publicdata be made public
Question was:Question was: does public disclosure of all 20 items (including key does public disclosure of all 20 items (including key
scientific datafields) give away competitive scientific datafields) give away competitive advantage?advantage?
does degree of loss of competitive advantage justify does degree of loss of competitive advantage justify keeping data hidden from the public?keeping data hidden from the public?
Many groups strongly against industry proposalMany groups strongly against industry proposal
Had to resolve this issue to move trial registration Had to resolve this issue to move trial registration alongalong
Ida Sim, WHO, 2006
Resolving Disclosure TimingResolving Disclosure Timing
Fall and Winter 2005:Open Comment Periods
web submissions from community on key topics
April 2006:April 2006: “Safe harbor” discussion session, Geneva “Safe harbor” discussion session, Geneva
high level consultation involving strategic thinkers, key players from all stakeholder groups patients and consumers scientists and clinicians industry (pharma, devices, biotech) medical journal editors ethicists, trade law experts, others
discussed balance of transparency vs. protection of competitive advantage
Ida Sim, WHO, 2006
Summary of Disclosure TimingSummary of Disclosure Timing
Public trust greatest if all 20 items made public Public trust greatest if all 20 items made public before first participant enrolledbefore first participant enrolledFull and immediate disclosure not a big threat to Full and immediate disclosure not a big threat to competitive advantagecompetitive advantage
big differences among companies in what they reveal big differences among companies in what they reveal and when and when why can one company reveal all outcomes why can one company reveal all outcomes
immediately and another none?immediately and another none?
““intellectual property” information can often be intellectual property” information can often be bought from “industry intelligence” sourcesbought from “industry intelligence” sources
no convincing evidence that disclosure would harm no convincing evidence that disclosure would harm competition or innovationcompetition or innovation may even promote innovationmay even promote innovation
Ida Sim, WHO, 2006
WHO Disclosure Timing PolicyWHO Disclosure Timing Policy
The benefits of full and immediate disclosure The benefits of full and immediate disclosure are greater than any potential loss of are greater than any potential loss of competitive advantagecompetitive advantage
WHO calls for full disclosure of all WHO calls for full disclosure of all registration items at time of registration and registration items at time of registration and before recruitment of the first participantbefore recruitment of the first participant
Sim et al, Lancet, 2006; 367:1631-3Sim et al, Lancet, 2006; 367:1631-3
Ida Sim, WHO, 2006
OutlineOutline
BackgroundBackground
Objectives, Governance, and StructureObjectives, Governance, and Structure
WHO Registry Platform OverviewWHO Registry Platform Overview
Intellectual Property ConcernsIntellectual Property Concerns
Current WorkCurrent Work
SummarySummary
Ida Sim, WHO, 2006
Registers NetworkRegisters Network
Want the fewest number of registers necessary to Want the fewest number of registers necessary to serve global needsserve global needs
easier to identify duplicates and assign UTRNeasier to identify duplicates and assign UTRN but countries have different needs (e.g., language, but countries have different needs (e.g., language,
research planning, research oversight)research planning, research oversight)
Current prioritiesCurrent priorities establishing a coordinated regional and international establishing a coordinated regional and international
approach to trial registrationapproach to trial registration
PAHO/WHO supports Latin American countries, BIREME, PAHO/WHO supports Latin American countries, BIREME, and others in plans for a Technical Committee and others in plans for a Technical Committee
setting, meeting, and monitoring quality, setting, meeting, and monitoring quality, deduplication, and accountability standardsdeduplication, and accountability standards
Ida Sim, WHO, 2006
Results ReportingResults Reporting
Standards currently in developmentStandards currently in development
required content being defined
must link to trial registration data set, must not have must link to trial registration data set, must not have Discussion or Conclusion sectionsDiscussion or Conclusion sections
when to report: within 1 year of study completionwhen to report: within 1 year of study completion
format: electronic, web-accessible, preferably Englishformat: electronic, web-accessible, preferably English
availability: open access (all entries free to public)availability: open access (all entries free to public)
venues: journals, repositories, databases, etc. venues: journals, repositories, databases, etc.
peer review not requiredpeer review not required
should be linked to trial registersshould be linked to trial registers
Ida Sim, WHO, 2006
Ensuring a Fair SystemEnsuring a Fair System
Everyone should be held to the same rulesEveryone should be held to the same rules assures registrants that they will not be at a assures registrants that they will not be at a
disadvantage compared to those who do not disadvantage compared to those who do not registerregister
Promoting and rewarding compliancePromoting and rewarding compliance
ICMJE policyICMJE policy
requirements by funding agencies (eg CIHR)? requirements by funding agencies (eg CIHR)? universities? countries? regulatory agencies? universities? countries? regulatory agencies?
linking to ethics review? linking to ethics review?
international laws/treaties? international laws/treaties?
Ida Sim, WHO, 2006
ResearchResearch
Need for better evidence to guide registration and reporting policies
Research topics under consideration registration compliance rates
extent of and nature of duplicate registration
consequences of duplicate registration
patterns of mis-reporting and consequences
evidence supporting various recommendations for trial reporting
Ida Sim, WHO, 2006
OutlineOutline
BackgroundBackground
Objectives, Governance, and StructureObjectives, Governance, and Structure
WHO Registry Platform OverviewWHO Registry Platform Overview
Intellectual Property ConcernsIntellectual Property Concerns
Current WorkCurrent Work
SummarySummary
Ida Sim, WHO, 2006
WHO Registry Platform…WHO Registry Platform…
Has finalized required registration itemsHas finalized required registration items
Is establishing a network of Primary and Associate Is establishing a network of Primary and Associate registers to coordinate registration worldwideregisters to coordinate registration worldwide
Will perform global deduplication of trials and issue Will perform global deduplication of trials and issue UTRNs to globally unique trialsUTRNs to globally unique trials
Will launch one-stop search portal of Primary Will launch one-stop search portal of Primary RegistersRegisters
Is dIs defining standards for minimum reporting of resultsefining standards for minimum reporting of results
Is pursuing compliance mechanisms for registration Is pursuing compliance mechanisms for registration and reportingand reporting
Ida Sim, WHO, 2006
Value Added of Registry PlatformValue Added of Registry PlatformWHO is only neutral body well-placed to define standardsWHO is only neutral body well-placed to define standards
Registration Data Set (and disclosure timing policy)Registration Data Set (and disclosure timing policy) results reportingresults reporting compliance enforcementcompliance enforcement
Single international network of high-quality registersSingle international network of high-quality registers simplifies, coordinates where to registersimplifies, coordinates where to register global accountability, sharing of best practicesglobal accountability, sharing of best practices
Duplication checking and unique trial identification (UTRN)Duplication checking and unique trial identification (UTRN) enhances global integrity and information quality enhances global integrity and information quality
One-stop search portal of registers worldwideOne-stop search portal of registers worldwide ””public face," transparency, restore trust/confidence public face," transparency, restore trust/confidence
Ida Sim, WHO, 2006
Conclusion Conclusion
Clinical trials transparency and public trust is a Clinical trials transparency and public trust is a global issueglobal issue
WHO taking lead on policy and technical WHO taking lead on policy and technical platform for coordinated trial registration and platform for coordinated trial registration and reporting worldwidereporting worldwide
Overriding principle is to promote scientific and Overriding principle is to promote scientific and ethical integrityethical integrity
Input from all stakeholders welcomeInput from all stakeholders welcome
Ida Sim, WHO, 2006
WHO Registry Platform TeamWHO Registry Platform Team Project CoordinatorProject Coordinator
Ida SimIda Sim
StaffStaff Esther AwitEsther Awit An-Wen ChanAn-Wen Chan Ghassan KaramGhassan Karam Patrick UnterlerchnerPatrick Unterlerchner
Other WHO Other WHO Metin GMetin Gülmezoglu lmezoglu Tikki PangTikki Pang Luis Gabriel Cuervo (PAHO)Luis Gabriel Cuervo (PAHO)