European & Developing Countries Clinical Trials Partnership (EDCTP)

Transcription

1 European & Developing Countries Clinical Trials Partnership (EDCTP) EDCTP funding opportunities Lara Pandya North-North Networking Officer EDCTP 13 June 2015

2 What is different in EDCTP2? New legal structure: Transition from EEIG to Association under Dutch law Expanded membership: Countries in sub-saharan Africa can become members Broader scope: Phase I-IV trials; health services optimisation research; NIDs and other emerging infectious diseases of particular relevance for sub-saharan Africa Increased magnitude: possibility for larger, more ambitious projects Operational process: Annual work plan, approved by EC and EDCTP General Assembly Call for proposals: broad, non-prescriptive, open calls Project funding: 100% funding + 25% indirect costs no cofunding requirement at the project level Private sector participation: Any legal entity can participate and receive funding 2

3 EDCTP2 targets Support more than 150 clinical trials Sustain or increase the proportion of clinical trials with African leadership Produce over 1400 peer-reviewed articles Sustain or increase participation of sub-saharan African countries in the partnership Support over 400 fellows, MSc and PhD students (encourage retention in sub-saharan Africa) Increase number of capacity building activities supporting the conduct of clinical trials to > 74 Ensure that at least 50% of public investment by PSs are integrated, aligned or coordinated Establish cooperation and launch joint actions with private and public funders, EU, WHO initiatives, development agencies, etc. 3

4 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; review by external international peer review committee; approval by EC; approval by GA EDCTP2 AWP for 2015 currently under review by EC 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 4

5 Funding mechanisms: Three types of Calls for Proposals from EDCTP Secretariat 1. Clinical trials Research and Innovation Actions (RIA) Strategic Research and Innovation Actions (SRIA) with major cofunding Consortia of 2 European PS and 1 sub-saharan African country 100% funding (RIAs) and for Strategic RIAs 50% from other funders (public or private) Broad non-prescriptive topics, bottom-up 2. Fellowships Training and Mobility Actions (TMA) 3. Capacity support Coordination and Support Action (CSA) Grants to individuals: Career development, Senior, other 100% funding Individual institutions or consortia for ethics, training, networking and regulatory activities 100% funding 5

6 Rules for participation and funding (1) Who can participate in EDCTP2 activities? Legal entities from anywhere in the world can normally participate in EDCTP2 activities, as long as the minimum eligibility criteria are fulfilled as specified in the Call for Proposals. What are the minimum eligibility requirements? Calls for Proposals on RIAs require the consortium to comprise at least three different legal entities. Two of the legal entities must be established in two different European Participating States and one of the legal entities must be established in a sub-saharan African country. All three legal entities shall be independent of each other. Calls for Proposals on CSAs or TMAs require at least one legal entity, unless otherwise specified in the call text. 6

7 Rules for participation and funding (2) Who can receive EDCTP2 funding? Legal entities established in sub-saharan African countries, in EU Member States, in overseas countries and territories linked to the EU Member States, or in Countries Associated to Horizon 2020 are automatically eligible to receive EDCTP2 funding. Within these eligible countries, any type of legal entity, public or private, is eligible to receive funding. Participants from outside sub-saharan Africa, the European Union or one of the Countries Associated to Horizon 2020 are, in principle, not eligible for funding and should fund their own participation in the project with funds from other sources. Ø E.g. Switzerland/Geneva-based international organisations can also be partners in EDCTP2 projects, but they will not be eligible to receive EU funding through EDCTP. 7

8 Calls for Proposals in 2014 (closed) In Q4 2014, the first 3 EDCTP2 Calls for Proposals were launched: 1. EDCTP-TDR Clinical Research & Development Fellowships, a collaborative activity with WHO-TDR, EFPIA, IFPMA and pharma companies Ø Ø TMAs Call closed 31 January 2015 (150 applications received) 2. Diagnostic tools for poverty-related diseases Ø Ø RIAs Call closed 2 March 2015 (95 applications received) 3. Maximising the impact of EDCTP research Ø CSAs Ø Call closed 16 March 2015 (14 applications received) 8

9 Calls for Proposals 2015: Improved treatment and clinical management of PRDs* (open) 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 open since 28 January 2015 Deadline for applications: 3 September 2015 * Pending EC approval 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) 9

10 Calls for Proposals 2015: Strategic projects with major cofunding* (open) To support distinct strategic actions (clinical research activities) which are part of a large-scale clinical trial in SSA with potential to achieve rapid advances in the field of PRDs Strategically important, ambitious projects addressing any EDCTP2 disease area Total activity cost 3.0 M Major cofunding ( 50%) from other funders (public or private) essential Call open since 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 10.0 M 2-5 / months 2 European PSs & 1 SSA country Two-stage (LoI; full proposal) * Pending EC approval 10

11 Calls for Proposals 2015: Research and capacity development in support of the EVD response* (open) Collaborative activity with WHO-TDR and MRC UK Build and strengthen regional, national, institutional and individual capacities to conduct high quality research during infectious diseases outbreaks Establish capacity building activities for health care and lab staff to ensure site preparedness; clinical testing of new prevention tools/treatments during outbreaks; implement best practices for building community and national health authority support in emergency situations Call open since 19 March 2015 Deadline for applications: 6 August 2015 Call budget: 1.4 M Maximum funding per project: 250,000 Expected nr/duration of grants: Minimum consortium criteria: Submission/evaluation process: 5-7 / months At least one legal entity Single-stage 11 * Pending EC approval

12 Planned 2015/2016 Calls for Proposals: Indicative topics* EDCTP Regional Networks (CSA; 2015 only) Vaccines for poverty-related diseases (RIA; 2016 only) Ethics and regulatory capacities - in collaboration with the Calouste Gulbenkian Foundation (CSA; annual) Strategic actions supporting large-scale clinical trials (Strategic RIA; annual call) Fellowships (TMA; annual) Ø Ø Ø Senior fellowships Career development fellowships EDCTP-TDR clinical research and development fellowships (in collaboration with WHO-TDR) * Pending EC approval 12

13 How to apply? Calls for Proposals are published on the EDCTP website ( and open for online application in EDCTPgrants ( 1. Find a suitable Call for Proposals 2. Find project partners in most cases 2 European and 1 African organisation must be on board 3. Create an account in EDCTPgrants 4. Carefully read the Guide for Applicants 5. Submit your application to EDCTPgrants 13

14 Evaluation How are proposals evaluated? EDCTP appoints independent experts to conduct a technical evaluation of submitted proposals and make funding recommendations to EDCTP. Ø Experts are external to EDCTP and, in performing their evaluation(s), are working in a personal capacity rather than as a representative of any organisation or scientific community. Proposals will be evaluated on 3 criteria: 1. Excellence 2. Impact 3. Quality and efficiency of implementation In parallel, or immediately following technical evaluation, proposals will be reviewed by independent ethics experts to check that they comply with ethical principles and relevant national, EU and international legislation. 14

15 Benefits & opportunities to participation in EDCTP2 EDCTP offers researchers: Opportunities to participate in large international clinical research consortia across Europe and Africa Increased networking opportunities, including with major pharmaceutical companies, public and private funders Other opportunities to engage include: Engage with national EDCTP representative, ministries, research councils and development cooperation agencies National funding opportunities à PSIAs EDCTP organises a bi-annual Forum (next in 2016) gathers about 500 scientists, stakeholders, policy makers Thematic stakeholder meetings (on average 1-2 per year) Register as an EDCTP expert reviewer 15

16 Thank you For additional information, please contact: Lara Pandya North-North Networking Officer

17 EDCTP Regional Networks of Excellence 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