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Strategic actions on product-related implementation research 2019
Deadline: Oct 10, 2019  
- 78 days

 Rural Development
 Health Care
 Pharmaceuticals
 Medical equipment
 Biological Sciences
 E-Health
 Biology
 Research
 Clinical trials

Background
Failure to translate research findings into policy and practice impedes research from achieving maximum public health benefit. New products and/or novel clinical interventions (i.e., new drug combinations/new formulations, clinical management algorithms), for poverty-related diseases (PRDs), may not reach the target populations, especially in resource-poor settings such as sub-Saharan Africa, because of challenges in ensuring the delivery and uptake of medical products into clinical practice. Further, barriers to adherence may compromise the effectiveness and public health benefit of new interventions. Therefore, concerted efforts by multiple stakeholders are needed to maximise the use of available, efficacious 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 to translate medical interventions of proven efficacy (diagnostics, drugs, vaccines, and microbicides) into routine care. Proposals may include testing of delivery methods to increase population coverage, retention in care and adherence to the intervention. Proposals must focus on PRDs in the scope of the EDCTP2 programme and should leverage major support from other funders. 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 as to why this is the appropriate design to provide robust evidence that can lead to policy change at national, regional and/or international level. Proposals must include a landscape analysis of the most important product-related implementation research gaps to justify the importance of the proposed research. Proposals must include a clear, credible plan of the pathway to achieving policy change or uptake within a defined timeline. This could relate to products that are not licensed or not eligible for reimbursement but then the applicants must indicate a credible uptake plan. The EDCTP Association considers that proposals for actions of between 24 and 48 months duration would allow this specific challenge to be addressed appropriately.

Expected impact
Projects funded under this call for proposals should:

  • 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;
  • contribute to policy change at the national, regional and/or international level.

 

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.

 

Submission and evaluation procedure
Two-stage application procedure. For the first stage, a letter of intent must be submitted by the first deadline. Successful applicants in the first stage will be invited to submit a full proposal for the second stage.

  • Proposals for Stage 1 must be submitted by 10 October 2019 at 17:00:00 CET via EDCTPgrants. Evaluation results for Stage 1 are expected to be made available by 21 December 2019.
  • Proposals for Stage 2 must be submitted by 16 March 2020 at 17:00:00 CET via EDCTPgrants. Evaluation results for Stage 2 are expected to be made available by 10 June 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 the evaluation of first-stage proposals under a two-stage submission procedure, only the criteria ‘excellence’ and ‘impact’ will be evaluated. Within these criteria, only the aspects in bold will be considered. The threshold for both individual criteria will be 4. For each indicative budget-split in the call conditions, the overall threshold, applying to the sum of the two individual scores, will be set at the level such that the total requested budget of proposals admitted to stage 2 is as close as possible to three times the available budget, and in any case, not less than two and a half times the available budget.

The actual level will, therefore, depend on the volume of proposals and funding request per proposal received. The threshold is expected to normally be set at 8 or 8.5.

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 to which 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 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 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.

 



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