Call for Proposals: Strategic Actions Supporting Large-scale Clinical Trials

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This call for proposal is part of the European & Developing Countries Clinical Trials Partnership (EDCTP) call to support clinical research and capacity building in sub-Saharan Africa.

Status:Active
Type of action:Research and Innovation Action (RIA)
Call budget:€43 M
Funding level:Up to 100% of eligible costs

Important Date
Stage 1 Open date: 3 July 2017, 17:00
Stage 1 Close date: 19 September 2017, 17:00
Stage 2 Open date: 15 December 2017, 17:00
Stage 2 Close date: 14 March 2018, 17:00

Expected number of grants: 2-4
Call identifier: RIA2017S

Description
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. Proposals for strategic actions that address the priorities outlined in the EDCTP Strategic Research Agenda and that address topics not covered in the scope of the other EDCTP2 calls for proposals launched in 2017 are particularly encouraged.

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 above-mentioned 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.
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Ufuoma is a Senior Editor and Director of Regulatory Policy at NLIPW. She assists clients in the protection of copyrights, trademarks and patents. She counsels clients regarding validity and infringement matters and has experience acting against the infringement of IP and addressing counterfeit issues. She holds a Masters degree (LL.M.) from Columbia Law School, New York and a law degree from the University of Nigeria (LL.B. Honors). She is admitted to practice law in Nigeria and in the State of New York. Ufuoma cut her teeth in the intellectual property practice groups of some of the largest law firms in Nigeria and has years of experience working with major non-profit organizations in New York. Email: uakpotaire@nlipw.com