European and Developing Countries Clinical Trials

Partnership

AEMI Seminar 13-15 Dec 2010

Dr Thomas NyirendaSouth-South Networking and

Capacity Development Manager, EDCTP

EDCTP

MISSION:To fight poverty sub-Saharan Africa by accelerating the development of new or improved drugs, vaccines and microbicides against HIV/AIDS, malaria and tuberculosis, and to improve generally the quality of research in relation to these diseases

• Through equal and effective partnership with Africa and African researchers

• Through integration of EU Member States national health research programmes

EDCTP Partnership

•16 European Countries (joined under article 169)•14 EU countries (Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom) + Norway+ Switzerland

•46 sub-Saharan Africa Countries

•Funding sources• European Commission• European Member States• Third Party: Public and private like minded organisations.

Partnership Structure

EDCTP Scope

Discovery &Pre-clinicalResearch

First inhumans

Lab and animaltesting

Phase I:Safety

Capacity development & networking

Clinical Trials

RegulatoryClinicalstudies

RegulatoryClinicalstudies

Phase II: Safety & limited efficacy

Phase III: Safety &efficacy

Pharmaco-vigilance

Policy,Practice

Policy,Practice

Phase IV: Long-term safety & Post-registration monitoring toinform policy

RegulatoryClinicalstudies

RegulatoryClinicalstudies

Phase II: Safety & limited efficacy

Phase III: Safety &efficacy

Developer of products have to declare accessibility and affordability to poor populationsBefore funding is provided to successful projects

S-S Networking

N-SNetworking

N-NNetworking

Personnel & Infrastructure

Short-term training

MSc

PhDC

aree

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men

t Fe

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ship

Capacity Development

Networking

EDCTP Strategy

Seni

or

Fello

wship

Ethics

Review

Regulatory

FrameworkClinical Trials

EDCTP Activities in Africa

• To date EDCTP Portfolio of funded projects: 142• Total value: 269 EUR M

• Clinical Trials: 44 Projects HIV/AIDS: 20 (Vaccines: 7, Treatment: 9 Microbicides: 4) Malaria: 10 (Vaccines: 2, Treatment: 8) Tuberculosis: 14 (Vaccines: 6, Treatment: 8)

• Capacity Development Career and Senior Fellowships: 27 Ethics & Regulatory: 41 TA, JPA, CT Register: 14

• Networking & NOE: 11

EDCTP Activities

• Benin• Botswana • Burkina Faso• Cameroon• Congo Brazzaville• Congo DRC• Cote d’Ivoire• Ethiopia• Gabon• Ghana• Guinea• Guinea-Bissau• Guinea-Conakry• Kenya• Madagascar• Malawi• Mali• Mozambique• Nigeria• Rwanda• Senegal• South Africa• Sudan• Tanzania• The Gambia• Uganda• Zambia• Zimbabwe

African Vaccine Regulatory Forum (AVAREF)

Pan-African Clinical Trials Registry (PACTR)

PACT Registry

African Vaccines Regulatory Forum

(AVAREF)

AFRICA CLINICAL

TRIALS PORTAL

CONSOLIDATED

REPORTING OF TRIALS

GROUP (CONSORT)

Current EDCTP Collaborations

Organisation Type Number

European Public 42

African Public 123

Non Profit 39

Industry 12

Total 21611

PDPs cofunding EDCTP funded Projects

HIV/AIDS• International AIDS Vaccine Initiative (IAVI): (919,782 Euro)• International Partnership for Microbicides (IPM): (1,477,443 Euro)

TB• AERAS Global TB Vaccine Foundation: (10,430,027 Euro)• Global TB Alliance: (8,970,066 Euros)

Malaria• Medicines for Malaria Venture: (601,578 Euro)• Drugs for Neglected Diseases initiative  (DNDi): (13,295 Euro)• European Vaccine Initiative (EVI): (1,984,738 Euro)

12

Contributions of third party

Challenges

• Ownership: Few African countries put funds in clinical trial activities (while EU prepares renewed support to 2018/20)

• African leadership: Lack of critical mass of African researchers on continent

• Enabling environment: Very few centres with adequate conditions to attract and retain the best trained researchers

• Supportive environment: Ethics & regulatory framework still needs strengthening in many parts of the continent

• Networking: South-South networking is still weak

• The East African Community (EAC) • The Secretary General of EAC (Associate Member)

• The Economic Community of Central African States (ECCAS)• The Secretary General of Organisation for the Coordination of the

Struggle Against Epidemics in Central Africa (OCEAC)

• The African Regional Committee of Health Ministers: • Ministry of Health – Ghana deputised by Ministry of Health - Zambia

• African Ministers of Finance or Ministers of Science and Technology • To be nominated

• The African Union (AU) Commission of Social Affairs• Commissioner of Social Affairs, Bience Gawanas,01 Dec 2009

African representation on EDCTP General Assembly since 2010

Thank you for your attention