Expected impacts of the calls under the 2023 work programme of the Global Health EDCTP3 JU

Activities funded under the 2023 calls for proposals should contribute to:

• Achieve SDG3 ‘Ensure healthy lives and promote well-being for all at all ages’ in sub-Saharan African countries;
• Enable the implementation of the short and medium term actions foreseen by the AU EU Innovation Agenda^[1] (expected to be adopted in June 2023) in the area of Public Health
• Provide evidence for informed health policies and guidelines within public health systems in sub-Saharan Africa and at international level;
• Strengthen clinical research capability in sub-Saharan Africa to rapidly respond to emerging epidemics;
• Enable a regulatory environment that can ensure effective development, delivery, and uptake of new or improved safe health technologies guaranteeing that trials in sub-Saharan African countries meet international standards;
• Increase cost effectiveness of public investment through collaboration of funders of clinical trials in the area of infectious diseases in sub-Saharan Africa;
• Strengthen health systems to ensure uptake of effective health technologies and innovations;
• Enhance sustainable global scientific collaboration in health research and international cooperation across sub-Saharan Africa.
• Improve opportunities for training of researchers and healthcare professionals in sub-Saharan Africa.

^[1]Working document of the AU EU Innovation Agenda available online at: https://research-and-innovation.ec.europa.eu/system/files/2022-02/final_au-eu_ia_14_february.pdf

Project results are expected to contribute to the following outcomes:

• Provide answers to research questions in the area of infectious disease clinical research of relevance for SSA and especially in the countries most severely affected by infectious diseases;
• Contribute to generate plausible solutions to improve uptake of innovations and new medical products;
• Increase the number of skilled infectious disease personnel working in SSA;
• Promote the career development and retention of skilled personnel in SSA;
• Strengthen the SSA countries’ clinical human capital base in Research and Innovation (R&I);
• Enhance talent retention and knowledge circulation and uptake across the SSA R&I landscape;
• Improve the attractiveness of infectious disease clinical research careers in SSA;
• Contribute to the generation of a critical mass of clinicians and institutional clinical research capacity in SSA;
• Enhance clinical research capacity in poverty-related diseases, especially in the countries with the highest infectious disease burden;
• Enhance the application of One Health approaches across SSA;
• Strengthen the ability of SSA countries to prepare for and to manage epidemic disease outbreaks;
• Encourage cooperation between researchers and clinicians in SSA with Africa CDC^[1], African Union Development Agency New Partnership for Africa's Development AUDA-NEPAD^[2], World Health Organization African Region (WHO-Afro)^[3], African Vaccine Regulatory Forum AVAREF^[4] and other organisations relevant for R&I;
• Establish sustainable and mutually beneficial collaboration between clinical research organisations within SSA and Europe;
• Foster a culture of collaboration with Global Health EDCTP3 like-minded funders working in SSA;
• Foster a culture of open science, innovation, and entrepreneurship in SSA;
• Improve equity in research between the genders and across anglophone, francophone and lusophone sub-Saharan Africa.

^[1]African Union Africa CDC Centres for Disease Control and Prevention https://africacdc.org/

^[2]https://www.nepad.org/

^[3]https://www.afro.who.int/

^[4]https://www.afro.who.int/health-topics/immunization/avaref

The Global Health EDCTP3 Training Networks aim to train and develop skilled, innovative, and resilient African researchers, scientists, clinicians, and other public health professionals working in the area of infectious disease research. The main objective is that these professionals can face current and future clinical research challenges, efficiently carry out clinical trials, mentor young scientists, implement research results, apply knowledge into development of products and services and/or analyse data to inform policy and practice for better health for all in sub-Saharan Africa (SSA). Through the training being offered to the fellows, important research questions within the framework of the Strategic Research and Innovation Agenda of Global Health EDCTP3^[1] will be addressed.

The Global Health EDCTP3 Training Networks will strengthen the clinical research capacity and attractiveness of clinical research in SSA countries. They will equip health research professionals with the right combination of research-related competences and capabilities to enhance their career perspectives.

^[1]https://commission.europa.eu/system/files/2022-01/ec_rtd_edctp3-sria-2022.pdf

The Global Health EDCTP3 Training Networks will implement training programmes through consortia of clinical research institutions, academia, industry, businesses (including SMEs) and other socio-economic actors from different countries across SSA and Europe, with the objective to strengthen the health research systems of the SSA countries with the highest disease burden. Proposals should include training programmes for researchers, scientists, clinicians and/or other public health professionals in the area of infectious disease research, with practical field research experience. The individuals being trained will carry out ambitious and relevant clinical research projects on infectious diseases affecting SSA.

Global Health EDCTP3 Training Networks proposals should be submitted by a consortium of institutions which must provide training through research programmes to early- to mid-career researchers based in SSA. The fellows must commit to be in Africa for a minimum of two years after completing their training and provide evidence to demonstrate this through a letter of support from their host institution(s).

Proposals should include institutions with a proven track record in the provision of high-quality research training and established regional and global collaborations. These may include research organisations, institutions of higher learning such as universities, national public health institutes or similar agencies, research councils, or other relevant institutions or government ministries. Proposals may also include industry, businesses (including SMEs) and other socio-economic actors.

These consortia should respond to well-identified needs on infectious disease research and innovation in SSA and describe the transfer of knowledge towards the countries with higher disease burden^[1], ensuring that the benefit of the training goes to less-experienced institutions/countries. South-South collaboration is strongly encouraged, although North-South collaboration is not excluded. Where appropriate, the training programmes should expose the fellows to collaboration with national departments of health as well as with international and regional organisations^[2].

The consortia should also offer transferable skills and competences relevant for innovation and fellows’ long-term employability, including financial administration, communication, commercialisation of results, entrepreneurship, intellectual property rights, etc.

The maximum duration of a training programme of a Global Health EDCTP3 Training Network should be 54 months.

The training programme should include two levels of fellows to be trained by experienced researchers, where the higher level provides training and mentorship for the lower one:

- Early-Stage Career Fellowships to support researchers and other members of clinical research teams from SSA to acquire specific skills in clinical research through placements in pharmaceutical companies, contract research organisations (CROs), clinical or academic affiliated research organisations and/or product development partnerships (PDPs). This category covers both hands-on-training apprenticeship and Master and PhD training arrangements where the candidates can spend part of their training and supervision at a more established or complementary institution with skill sets, expertise and or competences not available at the fellows' host African institution(s).

Target individuals should meet all the following criteria:

1. Citizens or residents from a SSA country with a higher infectious disease burden than the country of the host organisation;
2. Exceptionally, be citizens from non-SSA country willing to relocate to a SSA country with higher infectious disease burden;
3. Preference to citizens or residents from a SSA low-income countries with lower clinical research capacity^[3];
4. Be either postgraduate MD, MSc, or PhD candidate, in an area relevant to infectious diseases or clinical staff with experience in infectious diseases employed for the last 12 months in an organisation with a registered legal entity in SSA;

Duration of a single fellowship: between a minimum of 6 and a maximum of 36 months with the possibility of secondments up to a third of the single fellowship duration.

Expected minimum number of Early-Stage Career fellowships per proposal: 4, expected maximum number of Early-Stage Career fellowships per proposal: 10.

- Mid-Career Fellowships to support researchers and key members of clinical research teams from SSA in their mid-career to develop their clinical research skills. The objective is to promote career development and retention of post-doctoral clinical researchers in SSA, to equip the fellows with the ability to establish themselves as independent researchers and with the skills to initiate and manage their own research at host organisations in the SSA countries with the highest disease burden.

Target individuals should meet all the following criteria:

1. Be citizens or residents from a SSA country with higher infectious disease burden;
2. Exceptionally, be citizens from non-SSA country willing to relocate to a SSA country with higher infectious disease burden;
3. Preference to citizens or residents from a SSA low-income country with lower clinical research capacity²⁰;
4. MD/PhD related to infectious diseases or clinical research or a medical graduate with at least five years’ relevant research experience;
5. At least one publication in an international peer-reviewed journal.

Duration of a single fellowship: between a minimum of 6 and a maximum of 24 months and can have secondments up to a third of the fellowship duration.

Expected minimum number of Mid-Career fellowships per proposal: 2, expected maximum number of Mid-Career fellowships per proposal: 5.

The two training levels must be well integrated and designed to provide the required training support for the fellows. Training programmes should develop different training modules, including digital ones, addressing key transferable skills and competences common to all fields of clinical research, including research management and financial aspects, research collaboration and information-sharing, made possible by (digital) technologies (e.g. collaborative tools, opening access to publications and to other research outputs including data, FAIR data management, societal engagement and citizen science, etc.), and fostering the culture of Open Science, innovation and entrepreneurship as well as good scientific conduct such as research integrity.

Training programmes should have regular selection rounds following fixed deadlines or regular cut-off dates, allowing fair competition between candidates. The selection procedure for candidates must be open, transparent, and merit-based, in line with the Code of Conduct for the Recruitment of Researchers^[4]. The vacancy notices should be widely advertised in SSA countries and include the gross salary to be offered to the fellows (not including employer’s social contributions). The selection of the fellows should address gender and language/regional equity barriers.

Proposals must demonstrate the following:

• A high-quality training programme related to clinical research or implementation research on infectious diseases of importance in SSA, including One Health;
• An open, fair, and transparent procedure for selecting the fellows coming from different geographical regions of SSA, based on quality and with appropriate gender balance, with an active open promotion of the vacancies specifically addressed to female candidates, as well as to candidates from French speaking and Portuguese speaking countries to ensure that candidates from these groups can be well represented;
• Robust mentorship mechanisms to support the fellows through their training period up to completion;
• A robust monitoring and evaluation mechanism used to assess the career progression of the fellows, the impact of the training programme in the region and compile lessons learnt that can be used to inform future training programmes;
• The training programme must be conducted in SSA, in collaboration with relevant local or regional organisations such as National Public Health Institutes (and/or similar agencies), Ministries of Health, Research Councils and other relevant institutions;
• Whenever relevant, training programmes should expose fellows to collaboration with regional and international organisations, e.g., Africa CDC, AUDA-NEPAD, WHO-Afro, AVAREF and/or other organisations relevant for R&I;
• Training programmes should be designed with different training modules addressing also key transferable skills and competences concerning clinical research management including communication, ethical, regulatory, administrative, and financial aspects;
• Training programmes should include individual fellows training packages so that the fellows can deliver on their individual expected results;
• Proposals should also include support for meetings and conferences for the trainees to participate in the annual networking meetings, conferences and forums organised by relevant African organisations such as Africa CDC, EDCTP, WHO-Afro, AUDA-NEPAD, and other relevant events;
• Linkages with other EDCTP actions should be foreseen (e.g., EDCTP Networks of Excellence^[5] or Alumni Network^[6]).
• Capacity to provide adequate training on skills and competences relevant for innovation, e.g., entrepreneurship, commercialisation of results, intellectual property rights, etc.

To strengthen the clinical research capacity in the SSA regions with the highest disease burden, expert evaluators will be asked to take the possibility/likelihood of the transfer of knowledge particularly into account when evaluating the ‘impact’ criterion of the proposal.

Financial contributions from EDCTP-Association and third parties (e.g., foundations) interested in this scheme are encouraged to contribute to increase the budget, diversity, and impact.

Contributions for recruited researchers and institutions per person-month

Monthly contributions are based on the Marie Skłodowska Curie schemes (MSCA) contributions. To the living allowance a country correction coefficient^[7] for the recruited researcher will be applied to ensure equal treatment and purchasing power parity for all fellows. The mobility allowance will cover additional, private mobility-related costs (e.g., travel and accommodation costs), but not travel for professional or research purposes. A family allowance will contribute to mobility-related costs of researchers with family obligations which can be granted during the project.

Early-Stage Career (taken from the MCSA Work Programme 2023-2024 Doctoral Fellowships)

Mid-Term Development Career (taken from the MSCA Work Programme 2023-2024 Postdoctoral Fellowships)

^[1]https://www.who.int/data/gho/data/countries

^[2]International and regional organisations mentioned above

^[3]See Figure 4 – Scatter plot - severity/urgency of need vs relative research capacity – low-income countries at https://tdr.who.int/docs/librariesprovider10/essence/essence-mechanism-consultant-report-2020.pdf

^[4]https://euraxess.ec.europa.eu/jobs/charter

^[5]http://www.edctp.org/our-work/edctp-regional-networks-of-excellence/

^[6]http://www.edctp.org/our-work/fellowship-programme/edctp-alumni-network/

^[7]https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/wp-call/2023-2024/wp-2-msca-actions_horizon-2023-2024_en.pdf