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European and Developing Countries Clinical Trials Partnership

European and Developing Countries Clinical Trials Partnership. AEMI Seminar 13-15 Dec 2010. Dr Thomas Nyirenda South-South Networking and Capacity Development Manager, EDCTP. EDCTP. MISSION:

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European and Developing Countries Clinical Trials Partnership

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  1. European and Developing Countries Clinical Trials Partnership AEMI Seminar 13-15 Dec 2010 Dr Thomas Nyirenda South-South Networking and Capacity Development Manager, EDCTP

  2. 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

  3. 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.

  4. Partnership Structure

  5. EDCTP Scope First in Regulatory Regulatory Regulatory Regulatory Pharmaco- Policy, Discovery & humans Clinical Clinical Clinical Clinical vigilance Practice Pre-clinical studies studies studies studies Research Phase I: Phase II: Phase II: Phase III: Phase III: Phase IV: Policy, Lab and Safety Safety & Safety & Safety & Safety & Long-term Practice animal limited limited efficacy efficacy safety & testing efficacy efficacy Post-registration monitoring to inform policy C l i n i c a l T r i a l s C a p a c i t y d e v e l o p m e n t & n e t w o r k i n g Developer of products have to declare accessibility and affordability to poor populations Before funding is provided to successful projects

  6. EDCTP Strategy Career Development Fellowship PhD Senior Fellowship MSc Ethics Review Short-term training Capacity Development Regulatory Framework Personnel & Infrastructure Networking Clinical Trials S-S Networking N-N Networking N-S Networking

  7. 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

  8. 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

  9. African Vaccine Regulatory Forum (AVAREF)

  10. Pan-African Clinical Trials Registry (PACTR) African Vaccines Regulatory Forum (AVAREF) AFRICA CLINICAL TRIALS PORTAL PACT Registry CONSOLIDATED REPORTING OF TRIALS GROUP (CONSORT)

  11. Current EDCTP Collaborations

  12. 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)

  13. Contributions of third party

  14. 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

  15. African representation on EDCTP General Assembly since 2010 • 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

  16. Thank you for your attention

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