EDCTP Regional Networks – 2020

Description

Background
There are significant clinical research disparities and a very heterogeneous clinical research landscape for conducting clinical trials in sub-Saharan Africa across African researchers, institutions, countries and sub-regions. Fostering research collaborations is a means of addressing this challenge through investing in a joint pathway towards a stronger and sustainable sub-Saharan African clinical research landscape.

Scope
EDCTP has funded four regional networks(1), defined geographically as Southern(2), Eastern(3), Western(4), and Central Africa(5). These were established following a call for proposals in the EDCTP work plan 2015(6). The specific objectives of these EDCTP Regional Networks included: strengthening clinical research capacity in order to be able to conduct multi-country clinical trials to ICH-GCP standards; enhancing collaboration and optimising the use of resources and infrastructures within the network; offering training and mentorship aimed at promoting professional development and scientific leadership in clinical trials; strengthening South-South and North-South collaborations between researchers and institutions; encouraging and promoting networking and dialogue between researchers, communities and policy makers to maximise the impact of clinical research in Africa.

The purpose of this Call for Proposals is to provide continued funding to EDCTP Regional Networks that have demonstrated significant progress towards achieving the pre-defined deliverables set out in the 2015 call. The applicants must clearly demonstrate, point-by-point, in their proposal how they have progressed in the previous funding towards the following 2015 pre-defined deliverables:

Partnership:

• Publish at least three peer-reviewed scientific or policy publications as a demonstration of active collaboration and coordination.

• Organise at least one annual meeting, provide regular consortia communication (e.g. documented teleconferences), and develop annual work plans aimed at increased harmonisation of study methods, and sharing infrastructures.

Expertise:

• Initiate at least one ICH-GCP-compliant clinical trial in PRDs conducted and managed by appropriately qualified individuals within the network.
• Train or otherwise acquire at least five clinical research associates (CRAs) that are certified to monitor clinical trials and can be contracted by EDCTP, other funders or clinical trial sponsors to monitor the progress and quality of clinical trials.

Training:

• Develop a comprehensive training and mentorship plan to support the career development of talented individuals through dedicated courses, short term staff exchange programs, and active rotation process among sites for mentors/trainers and trainees.

Infrastructure:

• Incorporate at least one fully functional clinical laboratory, accredited to GCLP standards by recognised international or regional accreditation bodies such as, but not limited to, Kenya Accreditation Service (KENAS), South African National Accreditation System (SANAS), Institutio Portugues de Acreditação (IPAC), Comité Français d’Accreditation (COFRAC) to perform clinical trials research, which can be used by the network or contracted by an external clinical trial sponsor to support clinical trials.
• Develop a functioning data management service, which can be used by the network or contracted by an external clinical trial sponsor to support clinical trials.

Organisation:

• Develop a robust strategic business plan with demonstrated commitment and support from its constituent organisations; a transparent, fully-functional management and governance structure; a long-term strategy to ensure the viability, sustainability and progression of the network after the end of the EDCTP funding.
• Develop a communication strategy, including a regularly updated website and policies for dissemination data, results and other relevant information.

The four EDCTP Regional Networks are now invited to apply for an extension of up to 36 months. The maximum duration of the action is 36 months, with a foreseen start of the action no later than 1 October 2021. The scope of the proposal should cover at least three diseases in the scope of the EDCTP2 programme and include new value-adding deliverables. The networks should comprise sufficient participants to address all objectives but should not be too large to function and communicate effectively. Inclusion of new institutions is encouraged where appropriately justified, in particular when the institutions are based in countries, which currently have low uptake of EDCTP projects but high disease burden. Inclusion of younger scientists in the management and coordination of the proposals is also encouraged. While the participants, including the coordination, in the networks may change, including expansion or reduction in the number of partners, the core composition of partners should remain the same. The current call is restricted to applications from the four existing networks, and institutions that would like to join an application should contact the coordinator of the existing EDCTP Regional Network.

Applicants should have a clear governance structure, an independent advisory body and a transparent process for acquiring new network participants and for excluding non-performing network participants. The overall responsibility for the scientific management and direction of the network should be firmly based in sub-Saharan Africa. The networks should support complementary networking and data or resource sharing activities driven by digital platforms that enhance ongoing projects embarked on under EDCTP1 and EDCTP2. As such, EDCTP will support new activities that galvanise and expand on previous investments. New activities should add value and build on work previously funded by EDCTP. The networks should have a comprehensive research and training strategy that includes plans to: build and strengthen research capacity in previously neglected areas such as, but not limited to, co-morbidities between communicable diseases and non-communicable diseases (NCDs); address inequity in human capital development; mobilise research resources using existing e-learning and networking platforms; develop and retain indigenous research capacity with a definite career path for researchers; develop and support a network of skilled mentors who can lead the development of young clinical researchers, as well as being able to engage with national and regional policy makers, African development bodies and initiatives and the private sector about research and development plans. New and innovative ways should be proposed to break language barriers, ensure inclusion of women and support identified weaker institutions to facilitate integration and harmonisation of technologies, protocols and expertise. In addition, the contribution of the networks to strengthening regional or national ethics and regulatory boards are acceptable activities that EDCTP can support within successful proposals.

Due to the extraordinary global crisis of COVID-19 that is also affecting African countries, this topic should also be considered by the applicants.

Expected impact
Networks 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’.
• Contribute to a measurable and visible increase in collaborative research (south-south and north-south collaborations), competencies and capacity to conduct clinical trials.
• Demonstrate the ability to conduct clinical trials to ICH-GCP standard and to successfully compete for funding from local and/or international global health R&D funders.
• Demonstrate the ability to become sustainable after the end of the EDCTP funding.
• Enhance research capacity in poverty-related diseases and in clinical trials across Africa.

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 for participation set out below, depending on the type of action:
   • A network shall comprise a minimum of six legal entities from at least three different sub-Saharan African countries(7) and a minimum of two legal entities from two different European Participating States (8)(9)(10).
   • The requested EDCTP contribution per action shall not exceed EUR 4.5 million.
   • The maximum project duration shall be 36 months.
   • The call is restricted to applications from the four existing networks.

Notes
(1) Information about the four regional networks can be accessed here.

(2) Southern Africa is the geographical region that includes the following countries: Botswana, Lesotho, Madagascar, Malawi, Mozambique, Namibia, South Africa, Eswatini, Zambia, and Zimbabwe.

(3) Eastern Africa is the geographical region that includes the following countries: Burundi, Comoros, Djibouti, Eritrea, Ethiopia, Kenya, Mauritius, Rwanda, Seychelles, Somalia, South Sudan, Sudan, Tanzania, and Uganda.

(4) Western Africa is the geographical region that includes the following countries: Benin, Burkina Faso, Cape Verde, Gambia, Ghana, Guinea, Guinea-Bissau, Ivory Coast, Liberia, Mali, Mauritania, Niger, Nigeria, Senegal, Sierra Leone, and Togo.

(5) Central Africa is the geographical region that includes the following countries: Angola, Cameroon, the Central African Republic, Chad, the Republic of the Congo, the Democratic Republic of the Congo, Equatorial Guinea, Gabon, and São Tomé and Príncipe.

(6) The EDCTP regional networks 2015 call text can be found here.

(7) The following sub-Saharan African countries: Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo (Democratic People’s Republic), Congo (Republic), Côte d’Ivoire, Djibouti, Eritrea, Eswatini, Ethiopia, Equatorial Guinea, Gabon, Gambia, Ghana, Guinea, Guinea-Bissau, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, São Tomé and Príncipe, Senegal, Seychelles, Sierra Leone, Somalia, South Africa, South Sudan, Sudan, Tanzania, Togo, Uganda, Zambia, and Zimbabwe.

(8) This additional condition for participation according to RfP Art. 9.5 is required due to the nature and objectives of this Coordination & Support Action. It aims to build and strengthen regional, national, institutional and individual capacities to conduct clinical trials in line with international standards of good clinical practice by supporting networking at a regional level in sub-Saharan Africa. In light of this, it is necessary to have several African institutions within each network. It is in line with the activities called for by the EU legislator (EDCTP2 basic act, Annex II, activity 1c) 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 (EDCTP2 basic act, Annex I, objective 2b).

(9) The Participating States (European Partner States) are Austria, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, and the United Kingdom.

(10) ‘Sole participants’ formed by several legal entities (e.g. European Research Infrastructure Consortia, European Groupings of Territorial Cooperation, central purchasing bodies) are eligible if the above-mentioned minimum conditions are satisfied by the legal entities forming together the sole participant.

Procedure and application process

Submission and evaluation procedure
This is a single-stage application procedure. Proposals must be submitted by 23 July 2020, 17:00 CEST via EDCTPgrants. Evaluation results are expected to be made available by 30 November 2020.

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 (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 each individual criterion 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.
• Clarity, pertinence and importance of the strategic vision.
• Soundness of the concept.
• Quality of the proposed coordination and/or support measures.

 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 potential benefit of the research to the affected populations.
• Effectiveness of the proposed measures to exploit and disseminate the project results (including management of IPR), to communicate the project activities to different target audiences, and to manage research data, where relevant.
• Sustainability of capacity beyond the end of the grant, where relevant.
• Contribution to networking, where relevant, including alignment with national, regional and/or pan-African development plans, and with other actors intervening in the same field.
• Communicate the project activities to different target audiences.

 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).
• Quality of the leadership and a clear and effective governance structure.

 Financial provisions

• The call budget is EUR 18 million.
• The requested EDCTP contribution per action should not exceed EUR 4.5 million.
• The funding level is 100% of eligible costs.

Grant agreement
Participants in actions resulting from this call for proposals will be required to conclude a consortium agreement prior to the conclusion of the General EDCTP2 grant agreement (multi-beneficiary).

Application process

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

More information

• EDCTP2 Frequently Asked Questions about calls for proposals
• For specific questions related to this call for proposals, please contact: Michelle Nderu at nderu@edctp.org.
• For questions and issues about EDCTPgrants and the online application submission please contact EDCTP via edctpgrants@edctp.org.
• For guidance on applying to EDCTP, please refer to the Templates, guides and policies section of the EDCTP website.
• The EDCTP2 programme runs until the end of December 2024. Applicants should take into consideration the programme end date when planning their proposals.

Projects awarded under this call

CANTAM3
Central Africa Regional Network on Clinical Research (CANTAM): Strengthening Clinical Infectious Diseases Research in Central Africa
Fondation Congolaise pour la Recherche Médicale (FCRM), Republic of Congo, with partners from Cameroon, Democratic Republic of the Congo, Gabon, Germany, the Netherlands, United Kingdom and Zambia
Project coordinator: Professor Francine Ntoumi
Starting date: 1 July 2021
Duration: 36 months
Grant amount: EUR 4,499,897.50
Grant agreement: CSA2020NoE-3100

EACCR3
Eastern Africa Consortium for Clinical Research 3
Uganda National Health Research Organisation (UNHRO), Uganda, with partners from Kenya, the Netherlands, Rwanda, Sudan, Sweden, Tanzania, and United Kingdom
Project coordinator: Professor Pontiano Kaleebu
Starting date: 1 September 2021
Duration: 36 months
Grant amount: EUR 4,499,985
Grant agreement: CSA2020NoE-3102

TESA-III
Trial of Excellence in Southern Africa III
Fundaçao Manhiça (FM-CISM), Mozambique, with partners from Angola, Botswana, Eswatini, France, Malawi, Namibia, the Netherlands, South Africa, Spain, Zambia and Zimbabwe
Project coordinator: Dr Francisco Saúte
Starting date: 1 July 2021
Duration: 36 months
Grant amount: EUR 4,499,550
Grant agreement: CSA2020NoE-3104

WANETAM3
West African Network for TB, AIDS and Malaria
Réseau Africain de Recherche sur le SIDA (RARS), Senegal, with partners from Benin, Burkina Faso, Cote d’Ivoire, France, Germany, Ghana, Guinea, Mali, Nigeria, Portugal, Senegal, Togo and United Kingdom
Project coordinator: Professor Souleymane Mboup
Starting date: 1 August 2021
Duration: 36 months
Grant amount: EUR 4,499,998.75
Grant agreement: CSA2020NoE-3103