EDCTP Clinical Research and Product Development Fellowships – 2018

Description

Background
Researchers from sub-Saharan Africa who are involved in clinical research activities have limited opportunities to acquire experience and develop skills outside an academic or public sector setting for conducting clinical trials that adhere to stringent regulatory standards. As a result, there are few researchers and clinical staff from sub-Saharan Africa assuming leading roles in clinical research for poverty-related diseases (PRDs). The development of human research capacities through these fellowships will lead to enhanced and sustainable research competency in Africa on diagnostics, drugs and vaccines for PRDs, and support career progression and retention of researchers in sub-Saharan Africa.

As part of EDCTP’s capacity building efforts, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and EDCTP 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.

This call will have an incremental effect on the number of individuals trained, resulting in an increased impact on research and development capacity in sub-Saharan Africa. The partnership will ensure synergies between the different parties involved, and will facilitate communication with researchers and clinical staff, pharmaceutical companies, clinical research organisations (CROs) and product development partnerships (PDPs).

Scope
The purpose of this Call for Proposals is to provide funding towards actions that aim to support researchers and key members of clinical trial research teams from sub-Saharan Africa to acquire specific skills in clinical research and development through placements in pharmaceutical companies, PDPs and CROs.

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 sub-Saharan Africa where they are currently working on clinical research and clinical trials in the scope of the EDCTP2 programme*.  EDCTP supports research team members who are employed by a legal entity in a sub-Saharan African country. Placements 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.

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 (‘the applicant legal entity’) on behalf of the prospective fellow employed by that organisation. 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.

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 host organisations (pharmaceutical companies, CROs and PDPs) to train and develop specific clinical research skills of relevance to PRDs. The EDCTP2 grant includes funds for re-integration.

Host organisations may offer placements in 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 pharmaceutical companies, CROs and PDPs (i.e. host organisations) and available placements will be published on the EDCTP website. EDCTP will collaborate with the European Federation of Pharmaceutical Industries and Associations (EFPIA).

Expected impact
Projects funded under this Call for Proposals should:

• contribute to the achievement of SDG3 ‘Ensure healthy lives and promote well-being for all at all ages’
• support the development of human resources and should promote high quality research and development in sub-Saharan Africa
• add significantly to the development of promising researchers from sub-Saharan Africa, in order to enhance and maximise their contribution in research institutions in sub-Saharan Africa, including training of peers
• contribute to strengthening collaboration between research institutions, researchers and clinical staff in sub-Saharan Africa, pharmaceutical companies, CROs and PDPs.

Eligibility
A proposal will only be considered eligible if:

1. its content corresponds, wholly or in part, to the topic/contest description for which it is submitted
2. it complies with the eligibility conditions set out below, depending on the type of action:
   1. The applicant must be a legal entity established in sub-Saharan Africa and must be the home organisation employing the fellow**.
   2. The fellow must:
      1. be a post-graduate (MSc or PhD) or medical graduate with clinical and/or research experience in infectious diseases;
      2. have obtained their post graduate or medical graduate degree within 15 years of submission of the application;
      3. be a researcher or clinical staff member employed for the last 12 months in an organisation with a registered legal entity in sub-Saharan Africa, and who has been conducting clinical research activities in the scope of the EDCTP2 programme;
      4. provide a letter of support from the home organisation for the fellowship which is justifying the training needs of the fellow and explaining how the home organisation will benefit from the fellowship and how the reintegration of the fellow will be ensured***;
      5. not have been funded under this fellowship scheme before****.
   3. Placements sought shall be for a period of 15 months, following which there will be a re-integration period of up to 6 months
   4. The requested EDCTP contribution per action shall not exceed EUR 100,000.

Notes

* 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); echinococcosis; foodborne trematodiases; lymphatic filariasis; mycetoma; 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.

** 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).

*** The 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.

**** This 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.

Procedure and application process

Submission and evaluation procedure
This call has a single-stage application procedure.

• A full proposal must be submitted by 7 March 2019 at 17:00:00 CET via EDCTPgrants. Evaluation results are expected to be made available by 7 August 2019.

The full proposal should comprise of a proposed training plan reflecting the training needs of the applicant, a re-integration plan and the requested EDCTP contribution for the action.

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. Each criterion is scored between 0 and 5.

The following aspects are considered under the evaluation criteria:

1. Excellence

• Fit with the scope and objectives of the EDCTP2 Programme, the EDCTP strategic research agenda 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.

2. Impact

• Call specific aspects as listed under ‘expected impact’ in each individual call
• 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 in 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.

3. 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 time frame 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.

The applicant has a ‘right to reply’ to the expert assessments (rebuttal procedure).

Proposals scored above the threshold will be forwarded to prospective host organisations listed in the Call for Proposals. Host organisations interested in hosting a fellow will select up to five candidates for interview. Interviews are held between the potential host organisation, the candidate and the home organisation, following which a matching process of candidates and host organisations is conducted by EDCTP.

Financial provisions
The call budget is EUR 1.5 million.

The requested EDCTP contribution per project should not exceed EUR 100,000. The funding level is 100% of eligible costs.

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) within three months of receipt of the evaluation outcome letter.

Host organisations in actions resulting from this Call for Proposals will be required to sign up to the corresponding EDCTP charter, while fellows will be required to sign a letter of engagement with EDCTP prior to the conclusion of the EDCTP2 grant agreement.

 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.

Documents & info

Documents

• List of participating host organisations (PDF)
• Template of application form – Full Application (Word)
• Clinical Trial Competency table (Word)
• Guidance for applicants on preparing full proposals and annex 1 of the grant agreement (PDF)

More information

• For questions related to this call for proposals, please contact: Ms Michelle Nderu at nderu@edctp.org
• For questions and issues about EDCTPgrants and the online application submission please contact EDCTP via edctpgrants@edctp.org or +31 (0) 70 344 08 80
• 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.
• EDCTP2 policy on clinical trials registration, publication and data sharing (PDF)
• Global Code of Conduct for Research in Resource-Poor Settings (PDF)

Projects awarded under this call

DIALLO
Fellow: Dr Nouhoum Diallo

Université des Sciences, des Techniques et des Technologies de Bamako (USTTB), Bamako, Mali
Host organisation: Novartis Pharma AG – Global Drug Development, Basel, Switzerland
Starting date: 01 February 2020
Duration: 21 months
Grant amount: EUR 99,999
Grant agreement: TMA2018IF-2488

SOMA
Fellow: Mr Aboubakar Soma

Institut national de santé publique, Ouagadougou, Burkina Faso
Host organisation: Infectious Diseases Data Observatory (IDDO)/WorldWide Antimalarial Resistance Network (WWARN), University of Oxford, United Kingdom
Starting date: 01 February 2020
Duration: 21 months
Grant amount: EUR 98,500
Grant agreement: TMA2018IF-2484