Background
Antimicrobials are designed to kill or stop the growth of disease-causing pathogens, but many of them have become increasingly ineffective due to emerging resistance by the targeted bacteria, viruses, protozoa or fungi. Selection pressure naturally leads to the emergence of resistance whenever microbes are exposed to agents who are meant to kill them or inhibit their growth, and the potential spreading resistance can take days or years. Pathogens can also develop resistance to multiple agents, and as a result, very hard to control multi-drug resistant infections emerge and spread.
To guide and promote research and development of new antibiotics and vaccines, the WHO has established a list of antibiotic-resistant priority pathogens.* While new or improved antimicrobials is an essential tool to combat resistant pathogens at the patient level, the first line of defense for containing the spread of antimicrobial resistance (AMR) at the population level is an effective system to diagnose, detect, collect and integrate information about antimicrobial resistance on a large scale. In the context of large programmes to address AMR, isolated efforts will have very limited impact, and only coordinated actions will lead to a successful response against the emergence and spread of AMR.
Scope
The purpose of this call for proposals is to provide funding for clinical trials to be conducted in sub-Saharan Africa which aim to develop new or improved medicinal products (drugs and vaccines) or combinations thereof against pathogens from the WHO priority list that also fall within the scope of the EDCTP2 programme, specifically Campylobacter, Salmonella, Streptococcus pneumoniae, and Mycobacterium tuberculosis.
Proposals should include at least one clinical trial (phase I to IV) in sub-Saharan Africa. Proposals should clearly define the activities and mechanisms to be used within the project, including details of any collaboration with public authorities, international organisations or commercial partnerships that will be established in order to achieve the expected impact.
The proposal must include full details of the product development milestones including specific go/no-go criteria for the proposed clinical trial(s) as well as specific plans for the subsequent regulatory approval process.
Projects should include a detailed exploitation plan that describes how project results will be translated into products, policy or practice. The EDCTP Association considers that proposals for actions of between 36- to 60-months duration would allow this specific challenge to be addressed appropriately.
Expected impact
Projects funded under this call for proposals should contribute towards national and international plans for containment of antimicrobial resistance.
Eligibility
A proposal/application will only be considered eligible if:
Notes
*WHO: Prioritization of pathogens to guide discovery, research and development of new antibiotics for drug-resistant bacterial infections, including tuberculosis
**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
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
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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