Description

Background

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.

Scope

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.

Expected impact

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.

Notes

1. Countries as defined by the World Bank: low-income economies are defined as those with a GNI per capita, calculated using the World Bank Atlas method, of $1,045 or less in 2014; middle-income economies are those with a GNI per capita of more than $1,045 but less than $12,736.
2. http://www.who.int/tdr/capacity/strengthening/career_development/en/.
3. In the EDCTP2 programme, “poverty-related diseases (PRDs)” include HIV/AIDS, malaria, tuberculosis and the following neglected infectious diseases (NIDs): dengue/severe dengue; rabies; human African trypanosomiasis (sleeping sickness); Leishmaniases; cysticercosis/taeniasis; dracunculiasis (guinea-worm disease); echinococcosise; 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 Ebola or yellow fever.
4. For 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.

Procedure and application process

Selection process

The process includes the following steps:

• Eligible applications will be reviewed by an independent evaluation committee comprising experts jointly identified by the EDCTP and WHO/TDR
• Successful candidate fellows in the first stage will be shortlisted and prospective host organisations will be invited to identify preferential candidate fellows. The identification of preferential candidate fellows may include an interview of candidate fellows by the prospective host organisations.
• For the second stage (EDCTP only), the prospective host organisation, the preferred fellow and his/her home organisation must submit a comprehensive training plan and a re-integration plan that will be evaluated by a panel of independent experts.

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:

Excellence

• Fit with the scope and objectives of the EDCTP2 or WHO/TDR 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
• Suitability of the candidate, considering their track record, degree of independence and/or potential, and how the fellowship will further the individual’s career.
• Quality of the project and its fit with the fellow’s expertise and career development plan, including acquired competencies and skills to be developed further.

Impact

• 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
• Contribution of the fellowship to the fellow’s clinical research skills and career development.
• Contribution to strengthening clinical research capacity at the home or host organisation.
• Effectiveness of the proposed measures to exploit and disseminate results generated during the fellowship (including management of IPR), to communicate the fellowship activities, and, where relevant, to manage clinical data.
• Sustainability and retention of capacity post-award.

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).
• Suitability of the fellow’s home organisation to support the fellowship project.
• Intention of the fellow’s home organisation to develop and commit to a career post-fellowship or re-integration plan.

Financial provisions

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.

Eligibility

1. The fellow must

• be a post-graduate (MSc or PhD) or medical graduate with clinical and/or research experience in infectious diseases;
• have obtained their post graduate or medical graduate degree within 15 years of submission of the application;
• have been a researcher or clinical staff member employed for the last 12 months in an organisation with a registered legal entity in sub-Saharan Africa, conducting clinical research activities in the scope of the EDCTP2 and WHO/TDR programme;
• not have been previously funded under this fellowship scheme

For EDCTP:

1. The applicant must be a legal entity established in sub-Saharan Africa (the applicant legal entity) and must be the home organisation employing the fellow.(5)
2. Placements sought shall be 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 six months

For WHO/TDR:

1. The fellow must be a national or citizen, and resident in a LMIC
2. Placements sought shall be for a minimum period of 6 months and a maximum period of 12 months

Grant agreement

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.

Application process

• The application must be submitted online via EDCTPgrants
• Only registered users of EDCTPgrants system can apply for grants and therefore you are advised to register on the system as soon as possible

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):

• The application must be submitted by the applicant legal entity via EDCTPgrants by 2 Feb 2017. The evaluation results for the first stage will be available by 21 July 2017.
• Applications will be reviewed by an independent evaluation committee comprising experts jointly identified by EDCTP and WHO/TDR in compliance with the provisions set in the Rules for Participation of Horizon 2020 of the European Union and the EDCTP2.
• The evaluation committee evaluates eligible applications against the three predefined award criteria (see above)
• Candidate fellows scored above the first stage threshold will be shortlisted for consideration by prospective host organisations
• Prospective host organisations will invite preferred candidate fellows for an interview from the shortlist
• The identification of preferred candidate fellows by the prospective host organisation will be based on a match to their candidate profile and interview
• Host organisations rank candidates based on the interview and offer placements to their first ranked candidate
• For WHO/TDR a training plan will need to be submitted following which contractual arrangements begin.

Second stage application process (applicable to EDCTP only):

• Candidate fellows with a provisional offer of a placement by host organisations at the completion of the first stage will be invited to submit a full application, including a training plan, via EDCTPgrants by the second deadline.
• The candidate fellow and his/her home organisation (applicant) must submit a full application which includes a comprehensive training plan. The training plan is completed in consultation with the prospective host organisation.
• The full application will be evaluated by independent experts against the three predefined award criteria (see above)
• Applications ranked above the funding threshold will be invited to the grant preparation stage

Notes

1. Explanatory note: This 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, e.g., for cooperation with sub-Saharan Africa on building their capacity for conducting clinical trials in compliance with fundamental ethical principles, relevant legislations and international standards, and for extended cooperation with private partners (EDCTP2 basic act, Annex I, objectives 2b and 2d).

Documents and more information

Documents

• EDCTP2 annual work plan 2016 (PDF)
• List of host organisations for EDCTP-WHO/TDR  call for proposals 2016 (PDF)
• Letter of Intent – General Application Template (Word document)
• Sample training plan (PDF)

More information

For questions related to this funding scheme, please contact:

• TDR: Dr Pascal Launois at launoisp[at]who.int
• EDCTP: Ms Michelle Nderu at nderu[at]edctp.org
• For questions and issues about EDCTPgrants and the online application submission please contact EDCTP via edctpgrants[at]edctp.org or +27 (0) 21 938 0690.
• 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

Projects funded under this call

LIYOYO
Fellow: Dr Alphonce Liyoyo

Kibong’oto Infectious Diseases Hospital (KIDH), Siha-Kilimanjaro, Tanzania
Host organisation: Novartis Pharma AG, Switzerland
Starting date: 1 June 2018
Duration: 20 months
Grant amount: EUR 90,700
Grant agreement: TMA2016IF-1779

SHIBESHI ALEMAYEHU
Fellow: Dr Workineh Shibeshi Alemayehu

Addis Ababa University (AAU), Addis Ababa, Ethiopia
Host organisation: Merck KGaA, Germany
Starting date: 1 June 2018
Duration: 21 months
Grant amount: EUR 109,375
Grant agreement: TMA2016IF-1778

ZEYNUDIN
Fellow: Assistant Prof. Ahmed Zeynudin Kasim

Jimma University (JU), Jimma, Ethiopia
Host organisation: Julius Clinical Research BV, the Netherlands
Starting date: 1 June 2018
Duration: 20 months
Grant amount: EUR 108,725
Grant agreement: TMA2016IF-1661