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 the EDCTP Association’s capacity building efforts, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the EDCTP Association signed a Memorandum of Understanding (MoU) 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.
The 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 to skill local personnel in disease-endemic LMICs with 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 (TDR). 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.
The EDCTP Association and 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, academic affiliated research institutions, clinical research organisations (CROs), pharmaceutical companies and product development partnerships (PDPs).
This call will have an incremental effect on the number of individuals trained, resulting in an increased impact on research and development capacity in LMICs. The partnership will ensure synergies and facilitate communication between the different parties involved.
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 academic affiliated research organisations, CROs, pharmaceutical companies and PDPs. The home organisation may not be an affiliated entity of the host organisation2.
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 a LMIC where they are currently working on clinical research and clinical trials within the scope of the EDCTP2 programme3 and/or the TDR CDF programme4. Placements supported by the EDCTP2 programme are for a period of 15 months (3 months will be used to prepare for the placement), following which there will be a re-integration period of 6 months. Placements supported by TDR are for a minimum period of 12 months following which there will be a re-integration period of 12 months.
EDCTP: Proposals for an EDCTP Clinical Research and Product Development Fellowship (CRDF) must be submitted by an organisation with an established legal entity in sub-Saharan Africa.
TDR: Proposals for a TDR Fellowship must be submitted by a potential fellow employed by an established legal entity in any low or middle-income country (LMIC) around the world.
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 required and should demonstrate how the acquired 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. TDR will fund fellows employed by a research institution in any of the LMICs, to be placed in academic affiliated research institutions, CROs, pharmaceutical companies and PDPs in or outside Europe, whereas the EDCTP2 programme 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 CROs, pharmaceutical companies or PDPs to train and develop specific clinical research skills of relevance to PRDs.
Placements may include but would not be restricted to the following areas: design and conduct of clinical trial studies, including operational planning, management and evaluation; clinical development of vaccines including associated epidemiological studies; assessment of drug development programmes; diagnostics; biostatistics/epidemiology; data management and pharmacovigilance. A list of participating host organisations and available placements will be published on the EDCTP Association and TDR websites.
Projects funded under this call for proposals should:
A proposal/application will only be considered eligible if:
1For the current 2019 fiscal year, low-income economies are defined as those with a GNI per capita, calculated using the World Bank Atlas method, of $995 or less in 2017; lower-middle-income economies are those with a GNI per capita between $996 and $3,895; upper-middle-income economies are those with a GNI per capita between $3,896 and $12,055; high-income economies are those with a GNI per capita of $12,056 or more.
2An ‘affiliated entity’ is defined in this context as being either under the same direct or indirect control of a third legal entity or directly or indirectly controlling the host organisation, or directly or indirectly controlled by the host organisation.
3In the EDCTP2 programme, “poverty-related diseases (PRDs)” include HIV/AIDS, malaria, tuberculosis, 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, mycetoma, onchocerciasis (river blindness), schistosomiasis, soil-transmitted helminthiases, Buruli ulcer, leprosy (Hansen disease), trachoma, and yaws; diarrhoeal infections; lower respiratory infections; as well as emerging infectious diseases of particular relevance for Africa, such as Ebola or yellow fever.
4For WHO/TDR, “neglected infectious diseases (NIDs)” include: dengue/severe denque; rabies; chagas disease; 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.
5This additional condition for participation according to RfP Art. 9.5 is required due to the objectives of this Training & Mobility Action. It aims to support researchers and key members of clinical trial research teams from sub-Saharan Africa to acquire specific skills in clinical research and development. It is in line with the activities called for by the EU legislator (EDCTP2 Basic Act, Annex II, activity 1c and 1d) and contributes to the specific objectives of the EDCTP2 programme which calls, for example, for cooperation with sub-Saharan Africa on building their capacity for conducting clinical trials in compliance with fundamental ethical principles, relevant legislation and international standards, and for extended cooperation with private partners (EDCTP2 Basic Act, Annex I, objectives 2b and 2d).
6The points to be addressed in the support letter are elaborated in the application form and include: confirmation that the fellow is a current employee of the home organisation (details of contract duration should be included); confirmation that the home organisation supports this fellowship application; confirmation that the fellow is fully eligible in accordance with the criteria as set out in the call text; confirmation that the fellow will be supported with a leave of absence for the duration of the fellowship; confirmation that the fellow has the ability to successfully undertake the training he/she is applying for; details on how the fellowship will enhance the career development of the fellow; explanation of how the proposed training will strengthen the home organisation’s capacity to conduct clinical research upon return of the fellow; confirmation that the fellow will have a similar position at the home organisation once the fellowship has been completed.
7This additional condition for participation according to RfP Art. 9.5 is required due to the objectives of the EDCTP2 programme which requires that the capacity for conducting clinical trials in sub-Saharan Africa are built and strengthened (EDCTP2 Basic Act, Annex II). Allowing fellows in sub-Saharan Africa to only receive once a specific EDCTP2 fellowship will increase the number of different fellows supported and promoted under the EDCTP2 programme, and in turn, strengthen more broadly the corresponding clinical research capacity in sub-Saharan Africa.