Strategic actions supporting large-scale clinical trials
The purpose of this call for proposals is to support distinct strategic actions (clinical research activities) which are part of a large-scale clinical trial that has the potential to achieve rapid advances in the clinical development of new or improved medical interventions against PRDs.
There are multiple research opportunities arising continuously, some of which are of utmost strategic importance to advance clinical research in poverty-related diseases (PRDs). These research opportunities are often complex and resource-intensive, requiring financial investments that a single funder cannot bear. Extended international cooperation with other funders is vital to harness synergies and to ensure that the impact of research is maximised and resources and investments are leveraged.
The purpose of this Call for Proposals is to support distinct strategic actions (clinical research activities) which are part of a large-scale clinical trial that has the potential to achieve rapid advances in the clinical development of new or improved medical interventions against PRDs. Such large-scale clinical trials are often expensive and may require clinical research in different countries or on different continents, including outside of Europe and Africa. Applications for a strategic action should focus on clinical trials on PRDs in sub-Saharan Africa, and may address any disease within the scope of the EDCTP2 programme(1). Proposals that include phase III trials are encouraged.
Proposals must present the large-scale clinical trial in its entirety, clearly indicate for which part of the trial EDCTP2-funding is requested and how the financing of the other parts of the trial is ensured if applicable, and present its relevance to reaching the objectives of the EDCTP2 programme. The ambition and design of the proposed large-scale clinical trial as well as the relevance of the proposed strategic action for the large-scale clinical trial must be presented clearly. Supporting information on the composition and scale, as well as on the management structures and procedures of the large-scale clinical trial must be presented to enable assessment of their appropriateness.
EDCTP considers that proposals for activities 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 for actions of a different duration.
The large-scale clinical trial must be of a sufficient scale and ambition to justify EDCTP support in combination with financial support from other funders (i.e. from EDCTP2 Participating States and/or third parties). EDCTP considers that at least half of the costs of the large-scale clinical trial should be supported by other funders (i.e. from EDCTP2 Participating States and/or third parties) and that the foreseen total costs of the large-scale clinical trial should not be less than €3.0 million to provide this specific challenge with a strategic dimension.
Actions funded under this Call for Proposals should contribute to increased international cooperation among researchers and funders; catalyse research synergies; leverage resources and investments; and maximise the impact of global research in 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 clearly document major financial support from other funders at the level of the large-scale clinical trial will be considered to have a higher impact.
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.
- For the purpose of this call, PRDs include: HIV, malaria, tuberculosis, and also the following neglected infectious diseases (NIDs): dengue/severe dengue; rabies; human African trypanosomiasis (sleeping sickness); Leishmaniases; cysticercosis/taeniasis; dracunculiasis (guinea-worm disease); echinococcosis; foodborne trematodiases; lymphatic filariasis; onchocerciasis (river blindness); schistosomiasis; soil-transmitted helminthiases; Buruli ulcer; leprosy (Hansen disease); trachoma; yaws; diarrhoeal infections; lower respiratory infections; as well as emerging infectious diseases of particular relevance for Africa, such as yellow fever. Ebola Virus Disease vaccine development is specifically excluded from this call since it has already been extensively funded by other parts of the Horizon 2020 programme.
- 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.
- Legal entities in the following sub-Saharan African countries are eligible to apply: Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Democratic Republic of Congo, Republic of Congo, Djibouti, Equatorial Guinea, 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.
Procedure and application process
Submission and evaluation procedure
This is a two-stage application procedure. For the first stage, a letter of intent must be submitted by 13 October 2016 via EDCTPgrants. Applicants will be notified of the first-stage outcome before 22 December 2016. Successful applicants in the first stage will be invited to submit a full proposal for the second stage. The indicative deadline for submission of full proposals is 16 March 2017.
Evaluation criteria, scoring and thresholds
Following an admissibility and eligibility check, letters of intent and full proposals are evaluated by external, independent experts. Proposals are evaluated according to the criteria Excellence, Impact and Implementation. Each criterion is scored between 0 and 5.
Stage 1: Letters of Intent
For the evaluation of the first stage (Letters of Intent), only the criteria Excellence and Impact are evaluated. Within these criteria, only the aspects in bold will be considered. The threshold for both individual criteria will be 4. 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. 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. Successful applicants will be invited to submit a full proposal in the second stage.
Stage 2: Full proposals
For the evaluation of the second stage (Full Proposals), evaluation scores will be awarded for the criteria Excellence, Impact and Implementation. Each criterion is scored between 0 and 5. The threshold for individual criteria is 3 and the overall threshold for the sum of the three individual scores is 10. Applicants have the opportunity to submit a written response to the expert reviewers’ comments prior to an expert review committee meeting convened by EDCTP to finalise the funding recommendations.
The following aspects are considered under the evaluation criteria:
- Fit with the scope and objectives of the EDCTP2 programme 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) 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
- 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 for the field.
- 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, 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 where relevan
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 the evaluation of letters of intent only the criteria Excellence and Impact will be evaluated. Within these criteria, only the aspects highlighted above in bold will be considered.
For all applications involving human participants, and/or human tissues, cells or personal data, the evaluation process will include an assessment of ethical issues.
The call budget is 28 million EUR.
The requested EDCTP contribution per project should not exceed 15 million EUR. The funding level is 100% of eligible costs.
The Coordinator is required to sign a grant agreement with EDCTP (EDCTP2 multi-beneficiary grant agreement) within three months of receipt of the conditional award letter. All participants in the action must sign a consortium agreement.
Documents and more information
- EDCTP2 annual work plan 2016 (PDF)
- Template of application form – Letter of Intent (Word)
- Template of application form – Full Application (Word)
- Annex: Essential information for clinical trials applications (PDF)
- For questions related to this call for proposals, please contact: Dr Monique Rijks-Surette at Surette[at]edctp.org
- For questions and issues about EDCTPgrants and the online application submission please contact EDCTP via EDCTPgrants[at]edctp.org or +31 (0) 70 344 08 80.
- For guidance on online application procedure, please refer to the Guidance for applicants.
- For more information about EDCTP2 procedures, please refer to the EDCTP2 Grants Manual and EDCTP2 FAQs