International Cooperation
EDCTP – European and Developing Countries Clinical Trials Partnership
Presentation
Based in the Hague, Netherlands, the European and Developing Countries
Clinical Trials Partnership (EDCTP) was established in 2003 as an European
response to the crisis provoked by the three main poverty-related diseases
(HIV/Aids, tuberculosis and malaria), which altogether constrain prospects of
human and social development. EDCTP emanates from Article 185 of the Lisbon
Treaty, and aims at promoting an integrated approach to clinical research
towards prevention and treatment of those diseases, particularly in
Sub-Saharan Africa, the worst affected region in the world.
Portuguese is one of its working languages, together with English and French.
The EDCTP and the current EDCTP-2
EDCTP took place between 2003 and 2013 and was extended until 2015, having
obtained, as main outcomes:
- the approval of 207 projects in the area of clinical trials, capacity
development and network support in 30 countries in Sub-Saharan Africa and
with involvement of 351 institutions (2012) (see portfolio of projects);
- the launch of 4 networks of excellence promoting South-South cooperation,
which trained 400 African researchers;
- the establishment of the Pan African Clinical Trials Registry and the
African Vaccine Regulatory Forum.
The EDCTP-2 was approved by European co-decision on 6 May 2014,
stretches from 2014 thru 2024, and is equally funded by H2020 and EDCTP
participating states, i.e. 1.366 million euros altogether. Apart from
HIV/Aids, tuberculosis and malaria, the grouping of infectious neglected diseases
affecting Sub-Saharan Africa are included as well.
For more information about EDCTP-2, please check the following links:
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- Main goal: Acceleration of the development of new or improved tools
(drugs, microbicides, diagnostics and vaccines) against poverty-related
diseases (HIV/AIDS, tuberculosis, malaria and neglected infectious
diseases) in partnership with sub-Saharan Africa, by provision of a
critical mass of resources to support clinical trials.
- Other goals are: to coordinate the European national programmes to
effectively work in synergy and in mutual partnership with sub-Saharan
African stakeholders in conducting relevant clinical trials for the
development of the tools to fight HIV/AIDS, TB, malaria and NIDs; to
develop and strengthen the capacities in sub-Saharan Africa to ensure
that the relevant clinical trials are conducted using best practice; to
develop closer partnerships with the pharmaceutical industry and other
third parties, such as private foundations, to more effectively deliver
the objectives of the programme.
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- Disease-specific priorities for clinical trials and health
services/optimisation research, namely:
- – Treatment (evaluation of novel drugs and drug combinations in
advanced clinical stages)
- – Diagnostics (evaluation of diagnostic products)
- – Prevention (candidate vaccines testing)
- – Implementation research
- – capacity Building
- – Networking of European and African Programmes
- – Advocacy and Resource Mobilisation
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- The EDCTP-2 calls for proposals are supported through three distinct
types of Horizon 2020 'actions':
- – Research & Innovation Actions (RIA) are multicentre clinical
trials conducted by research consortia involving both European and
African research teams, with integrated capacity development and
networking elements.
- – Coordination & Support Actions (CSA) support activities that
strengthen the enabling environment for conducting clinical trials and
clinical research, including ethical review and regulatory capacity..
- – Training & Mobility Actions (TMA) are fellowships that focus on
the career development of individual researchers or research team
members.
- Calls are timely announced.
- You can check additional information about funding opportunities at
EDCTP website.
EDCTP Governance
EDCTP has originally been constituted as a European grouping of economic
interest. However, considering the need to increase representativeness of
involved countries, namely African ones; to adjust liabilities of
participating states; and enhance sustainability, the Association EDCTP has
been established on 10 April 2014. The association is composed of the
following bodies: General Assembly (supreme body), Board and Executive
Secretariat, apart from a Strategic Advisory Committee.
For the time being, the following countries have joined the Association EDCTP
(designated ‘participating states’): Angola, Austria, Burkina Faso, Cameroon,
Denmark, Ethiopia, Finland, France, Gabon, The Gambia, Germany, Ghana,
Ireland, Italy, Luxembourg, Mali, Mozambique, Netherlands, Niger, Nigeria,
Norway, Portugal, Republic of Congo (Brazzaville), Senegal, South Africa,
Spain, Sweden, Tanzania, Uganda, United Kingdom and Zambia.
Regardless of this list of members, it should be noted that EDCTP-2
activities may be implemented in all Sub-Saharan Africa countries, and, in
some calls, by any country affiliated with H2020.
Portugal's Participation
Portugal is a founding member of this partnership, and is being represented
by FCT and AICIB (Agency for Clinical Research and Biomedical Innovation)
through, respectively, delegates Andreia Feijão and Hugo Soares. The
Portuguese representation seeks, on the one hand, to build on the ongoing
work by the Portuguese scientific community operating in the area of EDCTP.
On the other hand, it aims at consolidating goals of scientific diplomacy
through the reinforcement of cooperation with strategic countries in
Sub-Saharan Africa (namely Portuguese-speaking ones), envisaging articulation
with other national, European and African public and private organisations
that promote health and development in Sub-Saharan Africa.
EDCTP goals are accomplished through manifold means. The major one is through
the development of research projects and other activities that emanate from
the calls for proposals launched by the EDCTP secretariat, mostly in linkage
with other funders. However, they are also achieved through projects and
activities implemented under the auspices of other funding schemes, including
national calls.
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- Between 2014 and 2016 the Portuguese contribution to the EDCTP goals
comprised two research projects; four
doctoral grants; and ten postdoctoral grants funded under various FCT
national calls. In Sub-Saharan Africa research was done in such
countries as Angola, Cape Verde, Democratic Republic of Congo and
Mozambique.
- In 2016 FCT has contributed 200.000 € to the cofunding of the
coordination and support action WANETAM (West African Network for TB Aids and
malaria), coordinated by Souleymane Mboup (Cheikh Anta Diop
University, Senegal), with participation of Henrique Silveira
(Instituto de Higiene e Medicina Tropical da Universidade Nova de
Lisboa), supported under the 2015 EDCTP Call for Networks of
Excellence. Project's total cost: 3.000.000,00 €.
- In 2017 FCT has contributed 200.000 € to the cofunding of the
coordination and support action LusoAfro Bio-Ethics (Strenghtening Bioethics
Committees in Lusophone African Region), coordinated by João
Schwalbach (Bioethics for Health National Committee, Mozambique), with
participation of Instituto de Higiene e Medicina Tropical and Faculdade
de Direito da Universidade Nova de Lisboa, supported under the 2016 EDCTP
Call on Ethics and Regulatory Capacities. Project's total cost:
291.496,26 €.
- In 2018 FCT has contributed 125.000 € to the cofunding of the
research and innovation action HAT-r-ACC (Towards an arsenic-free
oral treatment for human African trypanosomiasis due to Tb rhodesiense
as a tool for disease elimination), coordinated by Olaf
Valverde Mordt (DNDi, Switzerland), with the participation of Instituto
de Higiene e Medicina Tropical da Universidade Nova de Lisboa,
supported under the 2017 call targeting control and elimination of NIDs
through clinical trials. Project's total cost: 3.769.845,50 €.
- On April 20, 2018 FCT supported the session
Networking the networks: Maximising impact by strengthening
collaboration, capacity and quality of clinical research in sub-Saharan
Africa, under the auspices of the Regional Meeting of the World
Health Summit in Coimbra, with a 25.000 € contribution. From September
17 to 21 2018, FCT co-hosted the 9th EDCTP Forum with the Calouste
Gulbenkian Foundation in Lisboa with a 50.000 € contribution.
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- Coordination and support action TESA II (Trials of Excellence in Southern Africa II),
coordinated by Eusébio Macete (Fundação Manhiça, Mozambique), with
participation of PT-CRIN (as part of ECRIN), supported under the 2015
EDCTP Call for Networks of Excellence. Project's total cost: 3.000.000,00
€.
- Coordination and support action BERC-Luso (Biomedical Ethics and Regulatory
Capacity Building Partnership fo Portuguese-Speaking African
Countries), coordinated by Maria do Céu Patrão Neves (Ordem dos
Farmacêuticos), supported under the 2016 EDCTP Call on Ethics and
Regulatory Capacities. Project's total cost: 300.000,00 €.
- Research and innovation action Life study (Neonatal HIV early infant diagnosis
(EID) versus standard-of-care EID – Impact on infant health: a
feasibility study of point-of-care testing at birth versus at 6 weeks
of age on the uptake of ART and infant prophylaxis, and on rate of
infant survival, morbidity and retention in care), coordinated
by Ilesh Jani (National Institute of Health, Mozambique), with
participation of Nuno Taveira (Faculdade de Farmácia da Universidade de
Lisboa), supported under the 2016 EDCTP Call for Clinical trials to
reduce health inequities in pregnant women, newborns and children.
Project's total cost: 2.998.498,13 €.
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Apoio à Investigação Clínica nos PALOP: O papel da FCT e perspetivas
futuras, Seminário: Comissões de ética – uma ferramenta para o
desenvolvimento da investigação clínica em África, 9 March 2015,
Calouste Gulbenkian Foundation, Lisbon
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Reforço das Capacidades de Investigação Clínica em Angola através do
Programa EDCTP-2: Contributos para os Objetivos do «Plano de
Desenvolvimento Sanitário da República de Angola (2012-2015),
Workshop Horizon 2020 (organised by the Ministry of Science and
Education of the Republic of Angola and the Delegation of the European
Commission in Angola, 14 October 2014, Luanda
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The role of Portuguese research in the European & Developing
Countries Clinical Trials Partnership (EDCTP2), 21 February
2014, Instituto de Higiene e Medicina Tropical, Universidade Nova de
Lisboa
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International Scientific Cooperation in Neglected Tropical Diseases:
Portuguese Participation in EDCTP-2, 31 October 2013, Fundação
Calouste Gulbenkian, Lisboa
Contacts
Andreia Feijão (FCT delegate)
andreia.feijao@fct.pt
Tel: (+351) 213 924 356
EDCTP website
https://www.edctp.org/
The EDCTP and EDCTP-2 initiatives received funding, respectively, from the
sixth Framework Program for Research and Technological Development and the
European Union Research and Innovation Program Horizon 2020.