Background

There is an urgent need for new or improved products for tackling poverty-related diseases (PRDs). Late phase clinical trials find themselves at the critical juncture between clinical development and market authorisation by the regulators. These trials, which provide evidence to support the product approval process and/or influence policy and practice, are often large in scale, complex and expensive, beyond the resources of a single funder. Coordination and collaboration between partners and funders is essential to leverage the expertise, resources and investments needed that in turn accelerate the development of new or improved products for PRDs and maximise the impact of research funding investments.

Scope

The purpose of this Call for Proposals is to support strategic actions (clinical research activities) that are part of a large-scale clinical trial with the potential to achieve rapid advances in the clinical development of new or improved medical interventions (drugs, diagnostics, vaccines, microbicides) for PRDs. Proposals for a strategic action should focus on phase III study(ies) on PRDs within the remit of the EDCTP2 programme. The proposed EDCTP-funded study(ies) should be conducted in sub-Saharan Africa but may form part of a larger trial that is conducted globally. The clinical trial must be supported by an appropriate regulatory approval and access strategy and/or include plans for uptake into policy and practice at national or international level.

Proposals for a strategic action must also present the broader large-scale clinical trial in its entirety, including details of the component(s) of the trial for which EDCTP funding is requested and the component(s) that are to be financed from other sources. Proposals should make a clear distinction between the broader context (i.e. the large scale clinical trial) as opposed to the proposed action itself (i.e. the specific part of the clinical trial to be funded as a strategic action by the EDCTP Association). The clinical trial must be of a sufficient scale and ambition to justify EDCTP support in combination with financial support from other funders, such as EDCTP2 Participating States and/or third parties.

The total cost of the large-scale clinical trial should not be less than € 10 million and ideally at least half the cost of the large-scale clinical trial should be supported by funders other than the EDCTP Association. EDCTP considers that proposals for a strategic action of between 36 and 60 months duration would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals with different total costs and/or a different duration.

Expected impact

Actions funded under this Call for Proposals should contribute to increased international cooperation among researchers and funders; catalyse research synergies, and leverage resources and investments in order to achieve rapid advances in the development of new or improved products for PRDs. The large-scale clinical trial supported by the action should have the potential to achieve maximum impact in the field of PRDs and to make a significant contribution to the objectives of the EDCTP2 programme. Proposals that leverage major support from other funders, in particular financial contributions, at the level of the large-scale clinical trial will be considered to have a higher impact.

Eligibility

Consortia comprising a minimum of three independent legal entities are eligible to apply. Two of the legal entities must be established in two different European Participating States (2) of the EDCTP Association and one of the legal entities must be established in a sub-Saharan African country (3). All three legal entities shall be independent of each other.

‘Sole participants’ formed by several legal entities (e.g. European Research Infrastructure Consortia, European Groupings of Territorial Cooperation, central purchasing bodies) are eligible if the abovementioned minimum conditions are satisfied by the legal entities forming together the sole participant.

Notes:

1. Legal entities in the following European countries: Austria, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, and the United Kingdom.

2. Legal entities in the following sub-Saharan African countries: Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Democratic Republic of Congo, Republic of Congo, Djibouti, Eritrea, Ethiopia, Gabon, The Gambia, Ghana, Guinea, Guinea-Bissau, Ivory Coast, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, São Tomé & Príncipe, Senegal, Seychelles, Sierra Leone, Somalia, South Sudan, South Africa, Sudan, Swaziland, Tanzania, Togo, Uganda, Zambia and Zimbabwe.

Documents

- Template of application form – Letter of Intent (Word)

- Template of application form – Full Application (Word)

- Template for essential information to be provided for proposals including clinical trials (Word)

Financial provisions

The call budget is €43 million. The funding level is up to 100% of eligible costs.

Procedure and application process

This is a two-stage application procedure. For the first stage, a letter of intent must be submitted by 5 September. Successful applicants in the first stage will be invited to submit a full proposal. The indicative deadline for submission of full proposals is 14 March 2018.

The application must be submitted online via EDCTPgrants.