european and developing countries clinical trials partnership aemi seminar 13-15 dec 2010 dr thomas...
TRANSCRIPT
![Page 1: European and Developing Countries Clinical Trials Partnership AEMI Seminar 13-15 Dec 2010 Dr Thomas Nyirenda South-South Networking and Capacity Development](https://reader035.vdocuments.site/reader035/viewer/2022062321/56649e3b5503460f94b2cc49/html5/thumbnails/1.jpg)
European and Developing Countries Clinical Trials
Partnership
AEMI Seminar 13-15 Dec 2010
Dr Thomas NyirendaSouth-South Networking and
Capacity Development Manager, EDCTP
![Page 2: European and Developing Countries Clinical Trials Partnership AEMI Seminar 13-15 Dec 2010 Dr Thomas Nyirenda South-South Networking and Capacity Development](https://reader035.vdocuments.site/reader035/viewer/2022062321/56649e3b5503460f94b2cc49/html5/thumbnails/2.jpg)
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
![Page 3: European and Developing Countries Clinical Trials Partnership AEMI Seminar 13-15 Dec 2010 Dr Thomas Nyirenda South-South Networking and Capacity Development](https://reader035.vdocuments.site/reader035/viewer/2022062321/56649e3b5503460f94b2cc49/html5/thumbnails/3.jpg)
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.
![Page 4: European and Developing Countries Clinical Trials Partnership AEMI Seminar 13-15 Dec 2010 Dr Thomas Nyirenda South-South Networking and Capacity Development](https://reader035.vdocuments.site/reader035/viewer/2022062321/56649e3b5503460f94b2cc49/html5/thumbnails/4.jpg)
Partnership Structure
![Page 5: European and Developing Countries Clinical Trials Partnership AEMI Seminar 13-15 Dec 2010 Dr Thomas Nyirenda South-South Networking and Capacity Development](https://reader035.vdocuments.site/reader035/viewer/2022062321/56649e3b5503460f94b2cc49/html5/thumbnails/5.jpg)
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
![Page 6: European and Developing Countries Clinical Trials Partnership AEMI Seminar 13-15 Dec 2010 Dr Thomas Nyirenda South-South Networking and Capacity Development](https://reader035.vdocuments.site/reader035/viewer/2022062321/56649e3b5503460f94b2cc49/html5/thumbnails/6.jpg)
S-S Networking
N-SNetworking
N-NNetworking
Personnel & Infrastructure
Short-term training
MSc
PhDC
aree
r Dev
elop
men
t Fe
llow
ship
Capacity Development
Networking
EDCTP Strategy
Seni
or
Fello
wship
Ethics
Review
Regulatory
FrameworkClinical Trials
![Page 7: European and Developing Countries Clinical Trials Partnership AEMI Seminar 13-15 Dec 2010 Dr Thomas Nyirenda South-South Networking and Capacity Development](https://reader035.vdocuments.site/reader035/viewer/2022062321/56649e3b5503460f94b2cc49/html5/thumbnails/7.jpg)
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
![Page 8: European and Developing Countries Clinical Trials Partnership AEMI Seminar 13-15 Dec 2010 Dr Thomas Nyirenda South-South Networking and Capacity Development](https://reader035.vdocuments.site/reader035/viewer/2022062321/56649e3b5503460f94b2cc49/html5/thumbnails/8.jpg)
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
![Page 9: European and Developing Countries Clinical Trials Partnership AEMI Seminar 13-15 Dec 2010 Dr Thomas Nyirenda South-South Networking and Capacity Development](https://reader035.vdocuments.site/reader035/viewer/2022062321/56649e3b5503460f94b2cc49/html5/thumbnails/9.jpg)
African Vaccine Regulatory Forum (AVAREF)
![Page 10: European and Developing Countries Clinical Trials Partnership AEMI Seminar 13-15 Dec 2010 Dr Thomas Nyirenda South-South Networking and Capacity Development](https://reader035.vdocuments.site/reader035/viewer/2022062321/56649e3b5503460f94b2cc49/html5/thumbnails/10.jpg)
Pan-African Clinical Trials Registry (PACTR)
PACT Registry
African Vaccines Regulatory Forum
(AVAREF)
AFRICA CLINICAL
TRIALS PORTAL
CONSOLIDATED
REPORTING OF TRIALS
GROUP (CONSORT)
![Page 11: European and Developing Countries Clinical Trials Partnership AEMI Seminar 13-15 Dec 2010 Dr Thomas Nyirenda South-South Networking and Capacity Development](https://reader035.vdocuments.site/reader035/viewer/2022062321/56649e3b5503460f94b2cc49/html5/thumbnails/11.jpg)
Current EDCTP Collaborations
Organisation Type Number
European Public 42
African Public 123
Non Profit 39
Industry 12
Total 21611
![Page 12: European and Developing Countries Clinical Trials Partnership AEMI Seminar 13-15 Dec 2010 Dr Thomas Nyirenda South-South Networking and Capacity Development](https://reader035.vdocuments.site/reader035/viewer/2022062321/56649e3b5503460f94b2cc49/html5/thumbnails/12.jpg)
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
![Page 13: European and Developing Countries Clinical Trials Partnership AEMI Seminar 13-15 Dec 2010 Dr Thomas Nyirenda South-South Networking and Capacity Development](https://reader035.vdocuments.site/reader035/viewer/2022062321/56649e3b5503460f94b2cc49/html5/thumbnails/13.jpg)
Contributions of third party
![Page 14: European and Developing Countries Clinical Trials Partnership AEMI Seminar 13-15 Dec 2010 Dr Thomas Nyirenda South-South Networking and Capacity Development](https://reader035.vdocuments.site/reader035/viewer/2022062321/56649e3b5503460f94b2cc49/html5/thumbnails/14.jpg)
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
![Page 15: European and Developing Countries Clinical Trials Partnership AEMI Seminar 13-15 Dec 2010 Dr Thomas Nyirenda South-South Networking and Capacity Development](https://reader035.vdocuments.site/reader035/viewer/2022062321/56649e3b5503460f94b2cc49/html5/thumbnails/15.jpg)
• 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
![Page 16: European and Developing Countries Clinical Trials Partnership AEMI Seminar 13-15 Dec 2010 Dr Thomas Nyirenda South-South Networking and Capacity Development](https://reader035.vdocuments.site/reader035/viewer/2022062321/56649e3b5503460f94b2cc49/html5/thumbnails/16.jpg)
Thank you for your attention