Researchers from low- and middle-income countries (LMICs)(1) who are involved in clinical research activities have limited opportunities to acquire experience and develop skills for conducting clinical trials outside an academic or public sector setting. As a result, there are few researchers and clinical staff from LMICs assuming leading roles in clinical research for poverty-related diseases (PRDs). The development of human capacities through fellowships will lead to enhanced and sustainable research capacity in LMICs on diagnostics, drugs and vaccines for PRDs by supporting career progression and retention of researchers in LMICs.
As part of EDCTP’s capacity building efforts, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the EDCTP signed a Memorandum of Understanding in January 2013 to implement a fellowship scheme that offers placements in European-based companies to individual researchers and clinical staff from sub-Saharan Africa working in the implementation of clinical trials. Furthermore, the European Commission and the Bill & Melinda Gates Foundation signed a Memorandum of Understanding in June 2013 to cooperate in the fight against PRDs.
The WHO/TDR Career Development Fellowships (CDF) programme, which has been supported by the Bill & Melinda Gates Foundation and the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), offers targeted training in research and development within pharmaceutical companies and product development partnerships (PDPs) to develop highly skilled local personnel for disease-endemic LMICs to enhance competencies in clinical trials for drugs, vaccines and diagnostics on a broad range of infectious diseases of poverty. The CDF programme is implemented by the Special Programme for Research and Training in Tropical Diseases (WHO/TDR). WHO/TDR is hosted at the World Health Organization (WHO), and is sponsored by the United Nations Children’s Fund (UNICEF), the United Nations Development Programme (UNDP), the World Bank and WHO.(2)
The EDCTP and WHO/TDR decided to implement this fellowship scheme through a Joint Call for Proposals. This Joint Call will have a leverage effect on the number of individuals trained, resulting in an increased impact on research and development capacity in LMICs. The partnership will ensure synergies between the different parties involved, and will facilitate communication with researchers and clinical staff, pharmaceutical companies, PDPs and academic affiliated research institutions.
The purpose of this Joint Call for Proposals is to provide funding to actions that aim to support researchers and key members of clinical trial research teams from LMICs to acquire specific skills in clinical research and development through placements in pharmaceutical companies ,PDPs and academic affiliated research institutions.
The scheme targets junior to mid-career researchers or clinical staff (clinicians, pharmacists, medical statisticians, data managers, other health researchers) who are employed by a legal entity in LMICs where they are currently working on activities in the scope of the EDCTP2 programme(3) and the WHO/TDR CDF programme(4). Placements are for a minimum period of 12 months up to a maximum period of 18 months, following which there will be a re-integration period of 6 months (subject to the approval of a final re-integration plan).
The home organisation (applicant legal entity employing the prospective fellow) submits the application. Fellows must commit to return to their home organisation for a minimum of two years after completion of the fellowship. Fellows should identify the skills and training sought and should demonstrate how the experience would be applied upon return to the home organisation.
The Joint Call will include a joint evaluation and selection process in compliance with the provisions set in the Rules for Participation of Horizon 2020 and the EDCTP2 basic act. However, grant awarding and budget management will remain separate under the management of each organisation. WHO/TDR will fund fellows employed by a research institution in any LMICs to be placed in pharmaceutical companies, PDPs and academic research institutions in or outside Europe, whereas EDCTP will fund fellows employed by a sub-Saharan African legal entity (the fellow’s home organisation and applicant legal entity) to be placed in European-based pharmaceutical companies (the host organisation) to train and develop specific clinical research skills of relevance to PRDs. The EDCTP2 grant includes funds for re-integration, conditional upon the approval of a final re-integration plan.
The EDCTP and WHO/TDR will collaborate with EFPIA and IFPMA. A list of participating companies (i.e. host organisations) and placements available will be published on the EDCTP and WHO/TDR websites.
Actions funded under this Joint Call for Proposals will support the development of human resources and should promote high quality research and development in LMICs. Fellowships are expected to add significantly to the development of the best and most promising researchers from LMICs, in order to enhance and maximise their contribution in research institutions in LMICs, including training of peers. The actions should also contribute to strengthening collaboration between research institutions, researchers and clinical staff in LMICs, pharmaceutical companies, PDPs and academic affiliated research institutions.
Procedure and application process
The process includes the following steps:
Evaluation criteria, scoring and thresholds
Following an admissibility and eligibility check, 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. The threshold for individual criteria is 3 and the overall threshold for the sum of the three individual scores is 10.
The following aspects are considered under the evaluation criteria:
Quality and efficiency of the implementation
The grant covers one economy class return ticket (home – host organisation – home); a monthly stipend, health insurance, an allowance to cover essential educational support materials; and support to attend relevant meetings during the course of the fellowship The EDCTP grant also includes funds for re-integration.
The legal entity employing the successful fellow (‘home organisation’) is required to sign a grant agreement with EDCTP (EDCTP2 mono-beneficiary grant agreement with options for fellowships) or with WHO/TDR within three months of receipt of the conditional award letter.
The submission and evaluation procedure will be a two-stage application procedure for EDCTP2 and a single stage application procedure for WHO/TDR.
First stage application process (applicable to both EDCTP and WHO/TDR):
Second stage application process (applicable to EDCTP only):