Background
Poverty-related diseases (PRDs) remain the leading causes of morbidity and mortality in sub-Saharan Africa, especially during childhood. Despite progress in other age groups, effective treatment and prevention of PRDs in paediatric populations is often lacking and/or lagging. The frequent exclusion of children and adolescents from clinical trials and the paucity of available products that target this group are factors that contribute to this population having one of the lowest health indicators. Additional challenges relate to the limited financial incentives associated with the adaption of off-patent medicines to the specific needs of paediatric populations. Therefore, concerted efforts are needed to increase access to potentially life-saving, cost-effective interventions to prevent and treat PRDs in children and to enhance the use of existing interventions in this population.
Scope
Proposals should focus on the adaptation of existing medicinal products (drugs), including off-patent products, to the specific needs of children (0-17 years of age). Proposals may address any of the PRDs within the remit of the EDCTP2 programme. Proposals should include one (or more) clinical trials conducted in sub-Saharan Africa to assess the safety, efficacy and pharmacokinetics of the drug(s), and/or the development of age-appropriate formulations. Projects must assure that the clinical trials are conducted appropriately, in line with guidelines on pharmaceutical development of medicines for paediatric use*, respecting current legislation and considering the ethical aspects and particular needs of the study subjects and their families. Applicants should seek advice on the clinical trial design from the appropriate regulatory agency(ies) before developing the application. The EDCTP Association considers that proposals for actions of between 36 and 60 months duration would allow this specific challenge to be addressed appropriately.
The clinical need for paediatric dosing should be clearly explained in the proposal. The proposal must include full details of the strategy for the clinical paediatric development, including product development milestones and go/no-go criteria for the proposed clinical trial(s) as well as specific plans for the subsequent regulatory approval process, ideally a paediatric investigation plan, which should aim at obtaining a relevant market authorisation such as the Paediatric Use Marketing Authorisation (PUMA) or equivalent.
Expected impact
The actions supported under this call should have the potential to achieve maximum impact in the field and to make a significant contribution to the objectives of the EDCTP2 programme, and in particular:
Eligibility
A proposal/application will only be considered eligible if:
Notes
*Guideline on pharmaceutical development of medicines for paediatric use EMA, 1 August 2013
**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.
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
2. Impact
3. Quality and efficiency of the implementation
For this call for proposals, the Coordinator has a ‘right to reply’ to the expert assessments (rebuttal procedure).
Financial provisions
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
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