Strategic actions to maximise the impact of research on reducing disease burden, in collaboration with development cooperation initiatives – 2020

Description

Background
Failure to translate research findings into policy and practice prevents research from achieving maximum public health benefit. Despite substantial investment by public and private partners in the development of new prophylactics, diagnostics and treatments of poverty-related diseases (PRDs), these interventions may not reach their target populations or be used to their full potential. This is particularly the case in resource-poor settings such as sub-Saharan Africa, where health systems are either weak or not adequately prepared for the delivery and uptake of new or improved products and interventions and the monitoring of their effectiveness, safety and adherence. Therefore, concerted efforts by multiple stakeholders are needed to maximise the uptake of new or improved products and interventions in order to ensure that these innovations achieve their full potential in real-life clinical and community settings.

Scope
The purpose of this call for proposals is to support distinct strategic actions which are part of a large-scale programme of development cooperation actions. Projects should focus on research to maximise the uptake of products and health interventions in sub-Saharan Africa. This may include actions to: enhance the uptake of research findings or products and interventions; provide evidence to translate findings into policy guidelines and clinical practice; improve implementation, delivery and roll-out of interventions to increase population coverage, acceptability and adherence; improve the monitoring of product safety post-marketing and surveillance; pragmatic clinical trials evaluating interventions under real-world clinical care settings. The projects should be implemented in conjunction with development cooperation initiatives that are supported by national and/or international development cooperation initiatives and/or other funders, including relevant WHO initiatives where appropriate.*

Due to the extraordinary global crisis of COVID-19 that is also affecting African countries, this topic should also be considered by applicants.

Applications from multidisciplinary consortia involving public and/or private legal entities are particularly encouraged. The study(ies), which may be interventional or non-interventional in design and which must take place in sub-Saharan Africa, should be presented in detail and with clear justification for the proposed methodology and approach. Community engagement in design and implementation of the study(ies) is highly encouraged. Proposals must include a clear, credible plan of the pathway to achieve clinical practice and policy change or increase the uptake within a defined timeline. The proposals must relate to products, technologies or concepts that are already licensed, commercialised or otherwise approved.

Proposals should leverage major support from other funders and must present the large-scale programme of actions in its entirety and clearly describe: the actions in the large-scale programme for which EDCTP2 funding is requested; the actions to be supported by other funders; and how the financing from other funders is ensured. The large-scale programme of actions must be of a sufficient scale and ambition to justify EDCTP2 support in combination with financial (cash or in-kind) support from other funders. Ideally, at least half the cost of the large-scale programme of actions should be supported by funders other than the EDCTP Association, such as national and/or international development cooperation initiatives and/or other funders (such as EDCTP2 Participating States, relevant WHO initiatives or other third parties), in order to ensure complementarity and increase the impact of the results of EDCTP2-funded activities. The action should start no later than 1 October 2021 and must be completed before the end of 2024.

Expected impact
Projects funded under this call for proposals should:

• Enhance the sustainable implementation, coverage, availability, accessibility, acceptability and effectiveness of products and interventions in endemic areas in sub-Saharan Africa
• Contribute to change in policy and clinical practice at the national, regional and/or international level
• Increase collaboration with development partners, including increasing leverage of funding from development cooperation initiatives
• Contribute to the achievement of SDG3 ‘Ensure healthy lives and promote well-being for all at all ages’
• Contribute towards the reduction of the burden of PRDs in sub-Saharan Africa.

Proposals that leverage major support from other funders, in particular financial contributions from national and/or international development cooperation initiatives 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

*Explanatory note: The EDCTP2 basic act (Annex II, 2d, 2e and 3f) requires EDCTP to “establish cooperation and launch joint actions with Union, national and international development assistance initiatives, including where appropriate, relevant WHO initiatives, in order to ensure complementarity and increase the impact of the results of EDCTP-funded activities.”

**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, Eswatini, 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, 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 13 August 2020, 17:00 CEST via EDCTPgrants. Evaluation results are expected to be made available by 12 January 2021.

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.
• 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.
• 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 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 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 fulfil 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 23.4 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: Debora Bade at bade@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

GELA
Global evidence, local adaptation: Enhancing evidence-informed guideline recommendations for newborn and young child health in three countries in sub-Saharan Africa

South African Medical Research Council (SAMRC), South Africa, with partners from Malawi, Nigeria, Norway, South Africa and United Kingdom
Project coordinator: Dr Tamara Kredo
Starting date: 1 April 2022
Duration: 36 months
Grant amount: EUR 3,216,366.25
Grant agreement: RIA2020S-3303

INTEGRATION
Increasing the uptake of IPTp-SP through Seasonal Malaria Chemoprevention channel delivery

Université des Sciences, des Techniques et des Technologies de Bamako (USTTB), Mali, with partners from Burkina Faso, France, Italy and United Kingdom
Project coordinator: Dr Kassoum Kayentao
Starting date: 1 June 2021
Duration: 36 months
Grant amount: EUR 3,449,571.25
Grant agreement: RIA2020S-3302

LeishAccess
African leishmaniasis: From clinical research to access

Drugs for Neglected Diseases initiative, Geneva, Switzerland, with partners from Ethiopia, France, the Netherlands, Spain, Sudan, Switzerland, and Uganda
Project coordinator: Dr Jorge Alvar
Starting date: 01 July 2021
Duration: 36 months
EDCTP grant amount: EUR 4,296,791
Grant agreement: RIA2020S-3301

MULTIPLY
MULTIple doses of IPTi Proposal: a Lifesaving high Yield intervention

Fundación Privada Instituto de Salud Global Barcelona (ISGLobal), Spain, with partners from France, Mozambique, Sierra Leone, Switzerland and Togo
Project coordinator: Dr Clara Menéndez
Starting date: 1 May 2021
Duration: 40 months
Grant amount: EUR 4,722,431.25
Grant agreement: RIA2020S-3272

MVPE-CC
Strengthening the evidence for policy on the RTS,S/AS01 malaria vaccine: assessment of safety and effectiveness using case-control studies embedded in the Malaria Vaccine Pilot Evaluation

Kintampo Health Research Centre, Ghana, with partners from Germany, Kenya, Malawi, United Kingdom and United States
Project coordinator: Dr Kwaku Poku Asante
Starting date: 1 April 2021
Duration: 39 months
Grant amount: EUR 3,210,118.61
Grant agreement: RIA2020S-3310
Project website

XACT-19
Evaluating the impact of computer-assisted x-ray diagnosis and other triage tools to optimise Xpert orientated community-based active case finding for TB and COVID-19

The University of Cape Town Lung Institute (Pty) Ltd, South Africa, with partners from Denmark, Italy, the Netherlands, Zambia and Zimbabwe
Project coordinator: Professor Keertan Dheda
Starting date: 1 March 2021
Duration: 48 months
Grant amount: EUR 5,510,162
Grant agreement: RIA2020S-3295