Strategic actions supporting large-scale clinical trials – 2019

Description

Background
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.

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, 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.

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
A proposal/application will only be considered eligible if:

1. its content corresponds, wholly or in part, to the topic/contest description for which it is submitted
2. 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.

Notes

*The Participating States (European Partner States) are Austria, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, and the United Kingdom.

**The following sub-Saharan African countries: Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo (Democratic People’s Republic), Congo (Republic), Côte d’Ivoire, Djibouti, Eritrea, Ethiopia, Equatorial Guinea, Gabon, Gambia, Ghana, Guinea, Guinea-Bissau, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, São Tomé and Príncipe, Senegal, Seychelles, Sierra Leone, Somalia, South Africa, South Sudan, Sudan, Swaziland, Tanzania, Togo, Uganda, Zambia, and Zimbabwe.

Procedure and application process

Submission and evaluation procedure
This is a single-stage application procedure. Proposals must be submitted by 7 November 2019, 17:00 CET via EDCTPgrants. Evaluation results are expected to be made available by 30 March 2020.

Evaluation, scoring, and thresholds
Following an admissibility and eligibility check, full proposals are evaluated by external, independent experts. Proposals are evaluated according to the criteria Excellence, Impact and Implementation (see Article 15 of the Horizon 2020 Rules for Participation Regulation No 1290/2013). Each criterion will be scored out of 5. The threshold for individual criteria will be 3. The overall threshold, applying to the sum of the three individual scores, will be 10.

For all proposals involving human participants, and/or human tissues, cells or personal data, the evaluation process will include an assessment of ethical issues.

The following aspects are considered under the evaluation criteria:

1. Excellence

• Fit with the scope and objectives of the EDCTP2 programme, the EDCTP Association strategic research agenda and the call topic description.
• Importance, relevance/pertinence, and clarity of the objectives.
• The soundness of the concept and credibility of the proposed approach/methodology.
• Importance of the question being addressed and the rationale/need for the proposed clinical trial(s) or research study now.
• Excellence and appropriateness of the clinical trial design, including the proposed location(s) of the trial.
• The extent that the proposed trial will advance the field. In particular, how it differs from or complements any relevant planned, ongoing or recently completed trials internationally.
• Appropriate consideration of interdisciplinary approaches, and where relevant, use of stakeholder knowledge and gender dimension in research and innovation content.

2. Impact

• Call-specific aspects as listed under ‘expected impact’ in each individual call.
• The extent to which the outputs of the proposed work would contribute, at the European, African and/or International level, to each of the expected impacts listed in the work plan under the relevant topic.
• Likelihood to result in major advances in the field with a potential benefit of the research to the affected populations.
• Advancing the clinical development of new and improved products.
• Generalisability of the trial/study results beyond the immediate research setting in a way that will maximise the impact of the results.
• Contribution to improved disease management and prevention through changes in policy and practice, with the ultimate goal of improving public health.
• Contribution to strengthening the capacity in sub-Saharan Africa to conduct clinical trials.
• Effectiveness and quality of the proposed measures to exploit and disseminate the project results (including management of IPR) to communicate the project activities to different target audiences, and to manage research data.

3. Quality and efficiency of the implementation

• Quality and effectiveness of the work plan, including the extent to which the resources assigned to work packages, are in line with their objectives and deliverables;
• Appropriateness of the management structures and procedures, including risk and innovation management, and how responsibilities for research data quality and sharing, and security will be met.
• Complementarity of the participants within the consortium, and the extent to which the consortium as whole brings together the necessary expertise.
• Appropriateness of the allocation of tasks and resources, ensuring that all participants have a valid role and adequate resources in the project to fulfill that role.
• Feasibility and appropriateness of the methods and project management to achieve the objectives within the timeframe of the grant.
• Compliance with national and international standards of research, Good Clinical Practice, ethics, and safety-related issues.
• Participants have the operational capacity, to carry out the proposed work, based on the competence and experience of the individual participant(s).
• Competence of the participants and their investigators in conducting trials according to international standards of Good Clinical Practice (ICH-GCP).
• Involvement of sub-Saharan African researchers in the scientific leadership of the clinical trial.
• Arrangements and plans to take forward clinical development of the products under evaluation (where applicable).

For this call for proposals, the Coordinator has a ‘right to reply’ to the expert assessments (rebuttal procedure).

Financial provisions

• The call budget is EUR 20 million.
• The funding level is 100% of eligible costs.

Grant agreement
Participants in actions resulting from this call for proposals will be required to conclude a consortium agreement prior to the conclusion of the General EDCTP2 grant agreement (multi-beneficiary).

Application process

• The application must be submitted online via EDCTPgrants
• Only registered users of EDCTPgrants system can apply for grants and therefore you are advised to register on the system as soon as possible

More information

• EDCTP2 Frequently Asked Questions about calls for proposals
• For specific questions related to this call for proposals, please contact Dr Johanna Roth at roth@edctp.org.
• For questions and issues about EDCTPgrants and the online application submission please contact EDCTP via edctpgrants@edctp.org.
• For guidance on applying to EDCTP, please refer to the Templates, guides and policies section of the EDCTP website
• The EDCTP2 programme runs until the end of December 2024. Applicants should take into consideration the programme end date when planning their proposals.

Projects awarded under this call

MTBVACN3
MTBVAC in Newborns: Randomised, double-blind controlled phase 3 trial to evaluate the efficacy, safety and immunogenicity of MTBVAC administered in healthy HIV-unexposed uninfected and HIV-exposed uninfected newborns in tuberculosis-endemic regions of sub-Saharan Africa

Biofabri S.L., Pontevedra, Spain, with partners from Madagascar, the Netherlands, Senegal, South Africa, Spain
Project coordinator: Ms Ingrid Murillo
Starting date: 01 January 2021
Duration: 60 months
EDCTP grant amount: EUR 19,368,568
Grant agreement: RIA2019S-2652