European & Developing Countries Clinical Trials Partnership (EDCTP)

EDCTP and Open Source

2nd OSP Conference, 1-3 September 2015Dr Ole OlesenDirector of North-North CooperationEDCTP, The Hague, Netherlands

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EDCTP:Mission and objectives

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

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Objectives:1. Increase the number of medical interventions for poverty-related

diseases2. Strengthen capacity for clinical trials in sub-Saharan Africa3. Coordinate and align European national programmes4. Cooperate with other public and private partners5. Cooperation with EU initiatives, incl. development assistance

What EDCTP2 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, Regulatory3

The EDCTP2 Programme

Capacity for Clinical Trials in

Africa Clinical Trials in Africa on PRDs

Synergy

Who we are:EDCTP Association

EDCTP2 Participating States (PSs)14 European CountriesAustria, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden and UK14 African CountriesCameroon, Burkina Faso, Rep of Congo, Gabon, Ghana, Mali, Mozambique, Niger, Senegal, South Africa, Tanzania, Gambia, Uganda, Zambia

Countries that can receive funding•All sub-Saharan African countries•All EU MSs and Associated Countries

Example of Call for Proposals: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.

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Deadline on 15 October Grant scheme RIA (100% funding + 25% overhead)Call budget: € 35.0 MMaximum funding per project: € 15.0 MExpected nr/duration of grants: 3-5 / 36-60 monthsMinimum consortium criteria: ≥ 2 European PSs & ≥1 SSA countrySubmission/evaluation process: Two-stage (LoI; full proposal)

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EDCTP2 is part of H2020

Results: open access publication

Data: open access encouraged (how?)

IPR: belongs to grantees (if they want), minor issue in clinical trials?

Ownership: Results and data owned by grantees (if they want), but few commercial interests

Clinical trials: considerations

Clinical trials are highly regulated: ethics approval, legal approval, ICH, GCP, privacy protection etc

Clinical trials consist of interdependent steps:Protocol design; Approval; Execution; Data collection; Data

analysis

The main creative step is the protocol design

The most costly part is the execution of the trial

The collected data constitutes the main value of the trial8

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Is there an advantage to running an open trial?

1. Sharing data allows comparison across trials. Pharma, academia willing to share clinical data in PRD, but no common platform

2. Protocol design: Allow a wider scientific community to contribute.

Critical issues to consider

Are product owners willing to let go? Many scientists/companies/funders feel strong ownership of

their product candidate.

Will anybody contribute to an open protocol design? Will enough of the best experts contribute? "Classical" protocol design already involves large groups of experts

Who decides when a protocol is finalised?

Who will be the legal sponsor of a trial? Will anybody take on the legal sponsorship? 10

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How to get started: potential pilot project

Are there already suitable molecules?1. Call for expression of interest2. Selection of candidate molecule (selection criteria?)3. Set up an open platform for protocol design

(website?)4. Funder (e.g EDCTP) issues Call for legal sponsor and

research team to execute the trial 5. All data to be deposited in an accessible depository

(which format?)

Thank you

Ole Olesenolesen@edctp.org +31 70 344 0892

12www.edctp.org