European & Developing Countries Clinical Trials Partnership (EDCTP)

Transcription

1 European & Developing Countries Clinical Trials Partnership (EDCTP) Overview of EDCTP2 Dr Thomas Nyirenda South-South Networking and Capacity Development Manager 1

2 Background & Mission Background Established in 2003 by a co-decision of the European Parliament and Council: Article 185 Initiative (Ex 169) Pool research, activities to achieve greater impact against PRDs Promote integrated approach to health reseach in Europe In response to global declarations, MDGs and health crises caused by PRDs No economic incentive for private investments in PRDs Sparse public investments and fragmented know-how EDCTP-1: EDCTP-2: Mission EDCTP aims to support collaborative research that accelerates the clinical development of new or improved interventions to prevent or treat HIV/AIDS, tuberculosis, malaria and neglected infectious diseases in sub-saharan Africa 2

3 EDCTP2 Objectives 1. Increase the number of new or improved medical interventions for PRDs, including neglected ones 2. Strengthen cooperation with sub-saharan African countries, in particular on building their capacity for conducting clinical trials in compliance with fundamental ethical principles and relevant national, EU and internal legislation 3. Better coordinate, align and, where appropriate, integrate relevant national programmes to increase the cost-effectiveness of European public investments 4. Extend international cooperation with other public and private partners to ensure that the impact of all research is maximised and that synergies can be taken into consideration and to achieve leveraging of resources and investments 5. Increase impact due to effective cooperation with relevant EU initiatives, including its development assistance 3

4 Funding framework Main funder: European Commission Horizon 2020: This programme aims to promote Europe s global competitiveness by producing world-class science, removing barriers to innovation and encouraging the public and private sectors to work together in delivering innovation Article 185 initiative: Under this statute EDCTP2 will contribute to creation of a European Research Area (ERA) that enables researchers, research institutions and businesses to work and co-operate freely across boarders Other funders: European Member States, African Member States, partners 4

5 The EDCTP Association EDCTP2 Participating States (PSs) 14 European Countries Austria, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden and United Kingdom 14 African Countries Cameroon, Burkina Faso, Rep of Congo, Gabon, Ghana, Mali, Mozambique, Niger, Senegal, South Africa, Tanzania, The Gambia, Uganda, Zambia Countries that can receive funding All sub-saharan African countries All EU MSs and Associated Countries

6 EDCTP Governance General Assembly 1 Member from each Participating State (EC as Observer) advice Scientific Advisory Committee (SAC, 16 Members) Public-Public partnership between 26 sovereign states Board (5 Members, SAC Chair & EC as Observer) EDCTP Secretariat The Hague, NL Cape Town, ZA Owned by the PSs Minimum annual contribution of 200,000 (cash and/or in-kind) Operates as an independent legal entity Association under Dutch Law

7 EDCTP Funding levels Capacity for Clinical Trials in Africa Synergy Clinical Trials in Africa on PRDs 7

8 What EDCTP funds Diseases: HIV/AIDS, TB, Malaria, NIDs, emerging infectious diseases of particular relevance for Africa, including Ebola New tools and interventions: Diagnostics, drugs, vaccines and microbicides Capacity Development: Fellowships, Networks, Ethics, Regulatory 8

9 Strengthening of clinical trials capacity and the enabling environment

10 How EDCTP1: ( ) worked Grant funding: EDCTP/EU: 152 M PSs/SSA/third parties: 229 M 381 M Achievements: Number of calls 65 Number of grants awarded 254 Participating countries Sub-Saharan African 30 European 16 (involving 259 institutions posts supported) African leadership 72% PhD/MSc trained >400 Senior & Career Fellowships 56 Clinical trials 100 Ethics grants 75 10

11 EDCTP1 Regional Networks of Excellence for clinical trials Western Africa: WANETAM Website: Burkina Faso The Gambia Ghana Guinea-Bissau Mali Nigeria Senegal United States Strengthening of capacity for clinical trials Addressing inequality Proliferation and sharing of expertise and facilities Central Africa: CANTAM Website: Cameroon Congo, Republic of the Gabon France Germany Eastern Africa: EACCR Website: Kenya Sudan Ethiopia Tanzania Uganda Southern Africa: TESA Website: Botswana Malawi Mozambique South Africa Zambia Germany Sweden United Kingdom United States Zimbabwe France Germany Netherlands United Kingdom 64 institutions in 21 African countries Offered short- and long-term training to 1000 researchers Leveraged additional 24 M Published 38 peerreviewed papers

12 Process for launching Calls for Proposals in EDCTP2 Annual work plan (AWP) with call topics Priority setting through thematic stakeholder meetings; SAC; commissioned studies - bottom up approach Internal review; review by SAC; approval by GA; review by external international peer review committee; approval by EC; adoption by GA First EDCTP2 AWP approved AWP under review 1. Calls for Proposals 2. Participating States Initiated Activities (PSIAs) Selected, funded and managed by EDCTP Secretariat according to H2020 rules Selected, funded and managed by PSs according to national rules 12

13 Calls for Proposals from EDCTP Secretariat Consortia of 2 European PS and 1 sub-saharan African country 1. Clinical trials Either full funding (RIA) (100% of costs) or cofunding (SRIA) with other funders (PSs and/or third parties) Broad non-prescriptive topics, bottom-up 2. Fellowships Grants to individuals (TMA): Career development, Senior, other 100% funding 3. Coordination and Support Action Individual institutions or consortia for ethics, training, networking (NoE) and regulatory activities % funding

14 Calls for Proposals 2014: EDCTP-TDR Clinical Research & Development Fellowships Collaborative activity with WHO-TDR, EFPIA, IFPMA and pharma companies Support researchers and key clinical trial research team members from LMICs to acquire clinical research and development skills through placements in pharmaceutical companies and PDPs Targets junior to mid-career researchers or clinical staff employed in LMICs and working on activities in the scope of EDCTP and TDR EDCTP funds will support applicants from sub-saharan Africa placed at pharmaceutical companies in Europe Call closed 31 January 2015 (150 applications received) Maximum funding per grant: Up to 100,000 per year Expected nr/duration of grants: 25 (10 by EDCTP) / 6-24 months Minimum EDCTP consortium requirement: 1 sub-saharan African country Submission/evaluation process: Two-stage (LoI, training plan) 14

15 Calls for Proposals 2014: Diagnostic tools for PRDs Validation of clinical performance and/or implementation of new or improved diagnostic tools and technologies for PRDs, including as co-infections Advanced testing (e.g. evaluation and/or demonstration phase trials) or implementation studies in sub-saharan Africa Planning for WHO endorsement and/or implementation of the diagnostic tools and technologies upon successful completion of the project Priority given to point-of-care diagnostics for use in resource-limited settings. Call opened 2 December 2014 Deadline for applications: 2 March 2015 Call budget: 15.0 M Maximum funding per project: 3.0 M Expected nr/duration of grants: 4-8 / months Minimum consortium requirement: 2 European PSs & 1 SSA country Submission/evaluation process: Two-stage (LoI; full proposal) 15

16 Calls for Proposals 2014: Maximising the impact of EDCTP research Accelerate translation of research findings from EDCTP-funded projects into policy and practice to maximise their public health impact in SSA Developing methodological tools for translation into public health programmes/practices Optimising strategies for widespread adoption of research results Applications must be based on research findings from previously funded EDCTP activities (multidisciplinary consortia are encouraged) Call opened 16 December 2014 Deadline for applications: 16 March 2015 Call budget: 3.0 M Maximum funding per project: 500,000 Expected nr/duration of grants: 6-8 / months Minimum consortium requirement: One legal entity Submission/evaluation process: Single-stage (Full proposal) 16

17 Calls for Proposals 2015: Improved treatment and clinical management of PRDs Evaluation of new or significantly improved drugs or drug regimens in humans or to optimise the efficacy and use of existing therapeutics for PRDs, including co-infections of PRDs Should include one or more clinical trial(s) (phase I to IV) of therapeutics for PRDs to be conducted in sub-saharan Africa. Proposals for conducting phase II and/or phase III clinical trials are encouraged. Call opened 28 January 2015 Deadline for applications: 3 September 2015 Call budget: Maximum funding per project: Expected nr/duration of grants: Minimum consortium criteria: Submission/evaluation process: 35.0 M 15.0 M 3-5 / months 2 European PSs & 1 SSA country Two-stage (LoI; full proposal) 17

18 Calls for Proposals 2015: Strategic projects with major cofunding Strategically important, ambitious, large-scale research projects with potential to achieve rapid advances in the field of PRDs Clinical trials, related clinical research and/or capacity development efforts in SSA addressing any research area within EDCTP2 scope Total activity cost 3.0 M Must demonstrate financial commitment from other funders (PSs and/or third parties) Call opened 28 January 2015 Deadline for applications: 3 September 2015 Call budget: Maximum funding per project: Expected nr/duration of grants: Minimum consortium criteria: Submission/evaluation process: 20.5 M 100% of activity cost / 10.0 M 2-5 / months 2 European PSs & 1 SSA country Two-stage (LoI; full proposal) 18

19 Research and capacity development in support of EVD response Operational Research in support of Ebola virus disease (EVD) clinical studies Joint initiative with WHO-TDR and MRC UK Research that can complement current and future clinical research activities for the treatment, prevention and containment of EVD Policies to address ethical issues of experimental medications Developing health care capacities, site preparedness and lab testing Community engagement Call opened 19 March 2015 Deadline for applications: 6 August 2015 Call budget: 1.4 M Maximum funding per project: 100% of activity cost / 250,000 Expected nr/duration of grants: 5-7 / months Minimum consortium criteria: 1 legal entity per consortium Submission/evaluation process: Two-stage (LoI; full proposal) 19

20 EDCTP-TDR Clinical Research & Development Fellowships (2) Collaborative activity with WHO-TDR, EFPIA, IFPMA and pharma companies Support researchers and key clinical trial research team members from LMICs to acquire clinical research and development skills through placements in pharmaceutical companies and PDPs Targets junior to mid-career researchers or clinical staff employed in LMICs and working on activities in the scope of EDCTP and TDR EDCTP funds will support applicants from sub-saharan Africa placed at pharmaceutical companies in Europe Call opened 22October 2015 Deadline for applications: 28 January 2016 Maximum funding per grant: Up to 100,000 per year Expected nr/duration of grants: 30 (10 by EDCTP) / 6-24 months Minimum EDCTP consortium requirement: 1 sub-saharan African country Submission/evaluation process: Two-stage (LoI, training plan) 20

21 EDCTP Regional Networks Support regional networking in sub-saharan Africa and with Europe in order to build and strengthen regional, national, institutional and individual capacities to conduct clinical trials in line with the International Conference on Harmonization guidelines for Good Clinical Practice (ICH-GCP). Partnerships, training, developing and sharing facilities. Call opened 5 November 2015 Deadline for applications: 18 February 2015 Call budget: Maximum funding per project: Expected nr/duration of grants: Minimum consortium criteria: Submission/evaluation process: 12 M 100% of activity cost / 3M 4 / 36 months (initial +5 years) 6 legal entities in 3 SSACs One-stage (Full proposal) 21

22 Career Development Fellowships Provide funding to actions that aim to support junior to midcareer (0-5 years post MD/PhD) researchers ( fellows ) to train, develop their clinical research skills and remain working in Africa. Call opened 12 November 2015 Deadline for applications: 4 February 2015 Call budget: 1.5 M Maximum funding per project: 100% of activity cost / 150,000 Expected nr/duration of grants: Minimum consortium criteria: Submission/evaluation process: 10 / 36 months 1 sub-saharan African country One-stage (Full proposal) 22

23 Senior Fellowships Provide funding to actions that aim to support capacity development of potential African research leaders to serve as long-term trainer-of -trainers and mentors for junior researchers with emphasis on hands-on research training linked to clinical trials activities. Applicants should have >5 years research experience post MD/PhD Call opened 12 November 2015 Deadline for applications: 4 February 2015 Call budget: 2.5 M Maximum funding per project: 100% of activity cost / 500,000 Expected nr/duration of grants: Minimum consortium criteria: Submission/evaluation process: 5 / 60 months 1 sub-saharan African country One-stage (Full proposal) 23

24 Senior Fellowships Provide funding to actions that aim to support capacity development of potential African research leaders to serve as long-term trainer-of -trainers and mentors for junior researchers with emphasis on hands-on research training linked to clinical trials activities. Applicants should have >5 years research experience post MD/PhD Call opened 12 November 2015 Deadline for applications: 4 February 2015 Call budget: 2.5 M Maximum funding per project: 100% of activity cost / 500,000 Expected nr/duration of grants: Minimum consortium criteria: Submission/evaluation process: 5 / 60 months 1 sub-saharan African country One-stage (Full proposal) 24

25 Ethics and regulatory support Support sub-saharan African countries to establish and develop robust national medicines regulatory systems and capacities for ethical review of clinical research and use of medicinal products and technologies for use in humans. This scheme targets both National Ethics Committees (NECs) and National Regulatory Authorities (NRAs). Call opened 15 October 2015 Deadline for applications: 21 January 2015 Call budget: 1.5 M Maximum funding per project: 100% of activity cost / up to 300,000 Expected nr/duration of grants: 5-10 / months Minimum consortium criteria: Submission/evaluation process: 1 sub-saharan African country One-stage (Full proposal) 25

26 2016 planned calls (pending approval from EC) Research and Innovation Actions (RIA) vaccines development Strategic actions supporting large-scale clinical trials Establishment of a consortium for research and clinical management of patients in PRD epidemics in sub Saharan Africa Clinical trials and operational studies to optimise the use of products for poverty-related diseases in mothers, newborns, children and/or adolescents Coordination and support action (CSA) Strategic actions supporting health systems/services optimisation research and capacities Ethics & Regulatory Capacities Training and mobility Actions (TMA) Senior fellowships Career development fellowships EDCTP-TDR Industry fellowships AREF-EDCTP Preparatory Fellowships *AREF (African Research Excellence Fund) is MRC-UK sponsored initiative 26

27 EDCTP calls for proposals For all information on current and future calls go to 27

28 Thank you For additional information, please contact: Thomas Nyirenda