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Clinical Research and Product Development Fellowships (CRDF) – Joint call with WHO/TDR, the Special Programme for Research and Training in Tropical Diseases 2019

Status: Planned
Type of action: Training & Mobility Actions (TMAs)
Call budget: € 1.5 million
Maximum funding: €100,000
Funding level: 100% of eligible costs
Open date: 1 October 2019, 00:00
Close date: 28 February 2020, 17:00
Go to EDCTPgrants

Expected number of grants: 10-15

Call identifier: TMA2019IF

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 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.

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 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.

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 LMICs;
  • add significantly to the development of promising researchers from sub-Saharan Africa, in order to enhance and maximise their contribution in research institutions in LMICs, including training of peers;
  • contribute to strengthening collaboration between research institutions, researchers and clinical staff in LMICs, pharmaceutical companies, CROs, PDPs and academic affiliated research organisations.

 

Eligibility
A proposal/application 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 for participation set out below, depending on the type of action:
    • The applicant must be a legal entity established in sub-Saharan Africa and must be the home organisation employing the fellow5.
    • The applying 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;
      • 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;
      • 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 ensured6;
      • not have been funded under this fellowship scheme before7.
    • The requested EDCTP2 programme contribution per action shall not exceed EUR 100,000;
    • Placements sought shall be for a period of 15 months, following which there will be a re-integration period of up to 6 months.

 

For TDR:

  • The applying fellow must:
    • be national or citizen and resident in an LMIC;
    • be a post-graduate (MSc or PhD) or medical graduate with clinical and/or research experience in infectious diseases;
    • have obtained their post-graduate;
    • be a researcher or clinical staff member employed for the last 12 months in an organisation with a registered legal entity in an LMIC conducting clinical research activities in the scope of the TDR programme;
    • 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;
    • not have been funded under this fellowship scheme before.

 

Notes

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/taeniasisdracunculiasis (guinea-worm disease)echinococcosisfoodborne trematodiaseslymphatic filariasis, mycetoma, onchocerciasis (river blindness)schistosomiasissoil-transmitted helminthiasesBuruli ulcerleprosy (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.

Procedure and application process

Submission and evaluation procedure
This is a single-stage application procedure. Proposals must be submitted by 28 February 2020, 17:00 CET via EDCTPgrants. Evaluation results are expected to be made available by 28 July 2020 (interviews are planned for May-June 2020).

Evaluation, scoring and thresholds
Following an admissibility and eligibility check, full proposals will be reviewed by an independent evaluation committee comprising experts jointly identified by the EDCTP Association and TDR. Applicants above the threshold will be shortlisted and prospective host organisations will be invited to identify preferential candidate fellows. The identification of potential candidate fellows may include an interview of candidate fellows by the prospective host organisations.

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

  • Fit with the scope and objectives of the EDCTP2 programme, the EDCTP Association 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;
  • Quality of the mentorship and/or training plan.

 

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 with the potential benefit of the research to the affected populations;
  • Advancing the fellow’s clinical research skills and career development;
  • Contribution to the development of research independence and/or scientific leadership;
  • 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 beyond the end of the grant.

 

3. Quality and efficiency of the implementation

  • Quality and effectiveness of the work plan, including the 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 and/or host 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 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.

 

The TDR grant covers one economy class return ticket (home – host organization – home); a monthly stipend; health insurance; an allowance to cover essential educational support materials; support to attend relevant meetings during the course of the fellowship up to a maximum amount of USD 3,000. The grant also includes provisional funds for re-integration conditional upon the approval of a progress report and re-integration plan.

Grant agreement

EDCTP: The legal entity employing the successful fellow (‘home organisation’) will be required to sign a General EDCTP2 grant agreement mono-beneficiary with options for fellowships.
Home organisations in actions resulting from this call for proposals will be required to sign up to the corresponding EDCTP Association charter, while fellows will be required to sign a letter of engagement with the EDCTP Association prior to the conclusion of the EDCTP2 grant agreement.

TDR: The successful fellow, the home institution and the host organisation will be requested to sign a letter of award (the grant award) and a letter of agreement for all the intellectual property issues. In addition, the prospective host organization, fellow and his/her home organization will be required to develop and deliver a training plan.

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

 

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