Strategic actions supporting large-scale clinical trials 2019
Call budget: € 20 million
Funding level: 100% of eligible costs
Open date: 3 June 2019, 00:00
Close date: 7 November 2019, 17:00
There is an urgent need for new or improved products for tackling poverty-related diseases (PRDs). Late phase clinical trials (Phase III/IV) are at a 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.
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, vaccines, microbicides) or diagnostics, including multiplex diagnostic platforms, for PRDs. Proposals for a strategic action must focus on phase III/IV study(ies) or advanced field testing (in the case of diagnostics) on PRDs within the remit of the EDCTP2 programme. The proposed EDCTP2-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 appropriate regulatory approval and access strategy and/or include plans for uptake into policy and practice at the national or international level. The proposal must include full details of the product development milestones, as well as details of any consultation with/advice received from the regulatory agency(ies).
The Call for Proposals is open to all diseases within the scope of the EDCTP2 programme, with the exception of malaria that was covered by two targeted calls for Strategic Actions in the EDCTP2 work plan 2018. Proposals for strategic actions that address topics not covered in the scope of the other EDCTP2 calls for proposals launched in 2019 are particularly encouraged.
Proposals for a strategic action must 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 the 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. The EDCTP Association considers that proposals for a strategic action of between 36 and 60 months duration would allow this specific challenge to be addressed appropriately.
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.
A proposal/application will only be considered eligible if:
- its content corresponds, wholly or in part, to the topic/contest description for which it is submitted
- it complies with the eligibility conditions for participation set out below, depending on the type of action:
- At least three legal entities. Two of the legal entities shall be established in two different Participating States (European Partner States)* and one of the legal entities must be established in a sub-Saharan African** country. All three legal entities must 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 above-mentioned minimum conditions are satisfied by the legal entities forming together the sole participant.