What is European & Development Countries Clinical Trials Partnerships (EDCTP)?
The European & Developing Countries Clinical Trials Partnership (EDCTP) is a partnership between 14 EU countries, Switzerland and Norway, and 47 sub-Saharan African countries, which aims to reduce poverty by developing new clinical interventions to fight HIV/AIDS, malaria and tuberculosis in sub-Saharan Africa.
What are the main objectives of EDCTP?
The main objectives of EDCTP are:
- Acceleration of the development of new clinical or improved interventions, in particular drugs, microbicides and vaccines to fight HIV/AIDS, malaria and tuberculosis in developing countries through conducting and supporting clinical trials especially for phases II and III and generally to improve the quality of research on these diseases
- Fostering the integration of the national scientific health research programmes of the European Member States
- Strengthening of the related research and development capacity in sub-Saharan Africa. This includes securing of an enabling environment for best practices that includes capacity development for Good Clinical Practice (GCP), sound ethical review and a strong regulatory framework.
What is EDCTP’s mandate?
The basis for all EDCTP’s activities is formed by Article 169 of the European Treaty.
What does 169 Article stand for?
Article 169 of the European Treaty enables the European Union to participate in research programmes undertaken by several European Member States, including participation in the structures created for the execution of national programmes. EDCTP is the first formal structure created within the scope of Article 169. The originality of Article 169 is related to the fact that the proposal comes from the Member States.
What is the main difference between EDCTP and other research programmes in the field of HIV/AIDS, malaria and tuberculosis?
EDCTP is the first joint programme to bring together the efforts of European Member States aimed at developing and evaluating new vaccines and drugs against HIV/AIDS, malaria and tuberculosis. Therefore, it is an organisation which links research activities undertaken in similar research projects by different EU Member States.
Why does EDCTP only focus on sub-Saharan African countries?
Sub-Saharan Africa is the region which is worst affected by HIV/AIDS, TB and malaria:
- The number of people living with HIV worldwide in 2007 was estimated at 33.2 million. One in every three people in the world living with HIV lived in sub-Saharan Africa, a total of 22.5 million
- Over 1.5 million people are infected with TB in this region each year. In recent years this number has been rising rapidly, largely due to high prevalence of HIV
- 90% of malaria deaths occur in sub-Saharan Africa. Malaria kills 3000 children every day in Africa — that is a million a year.
Therefore, there is an apparent urgency to bring research expenditure in that area in line with the size of the gap in expenditure. Depending on future developments, it may be required to extend the scope to other developing countries.
Do you also fund projects based in countries other than sub-Saharan African countries?
At the moment EDCTP is only focusing its efforts on supporting sub-Saharan African countries within the framework based on a partnership between 14 European Union countries, Switzerland and Norway. On our website and in the call texts you will find a list of EDCTP-EEIG Member States and sub-Saharan African countries.
What is the overall budget of EDCTP, and how will it be allocated?
The overall budget of EDCTP is around €400 million for 7 years. This budget consists of two components. The national contributions of the Member States is estimated at least €200M. A financial contribution of the European Commission in the sum of €200 million will be made to increase the impact of EDCTP. Additional cofunding is sought from other sources, whether public or private.
I would like to receive updates from EDCTP. What can I do to receive them?
You can subscribe to the EDCTP Newsletter or visit our webpage for regular updates.
What types of grants does EDCTP offer?
EDCTP offers grants that focus on clinical trials (which are the principal function of EDCTP) as the core and use networking and capacity development to create a sustainable environment for conducting high-quality medical research in sub-Saharan Africa. The grants are thus used to support integrated projects, that combine clinical trials with networking and capacity development activities. EDCTP also offers grants that focus specifically on networking and capacity strengthening in Africa: Senior Fellowships, Ethics review and Regulatory Affairs and Networks of Excellence.
How can I apply for an EDCTP grant?
Once a call for proposals is published on the EDCTP website and in relevant scientific journals an applicant can apply for funding if their study corresponds with the call text requirements. Applications need to be submitted through eligible and legal institutions from Africa or from European Member States, involving a minimum of two European countries and/or African institutions. The European Member States should be responsible for cofunding the project, aiming at a minimum of 50% of the estimated resources.
Applicants should complete a full proposal (using the template provided) outlining the objective of their plan and details of all participants. Applications are then sent to the EDCTP secretariat via email (the link is published on the website), and must be received before the allotted deadline to be considered.
Are you open to prospective proposals at any time of the year?
Unfortunately EDCTP can only consider proposals that were submitted in response to a call for applications.
Who can apply for EDCTP funding?
Anyone can apply for EDCTP funding, on two conditions. Proposals should involve at least one Sub-Saharan African institution as well as two institutions from different EDCTP-EEIG Member States, and the proposal should follow the published call guidelines closely in order to be accepted for review.
How do I submit an application?
If your proposal is suitable for a selected call then you should download the application form, complete it fully, and email it to proposals@edctp.org before the specified deadline.
Is there a limit to the number of applications I can submit?
Yes, you can only be a Project Coordinator (PC) on one application. However, Project Coordinators may also be a co-applicant (e.g. second or third named applicant) or collaborator on any number of new applications.
How will the application be assessed?
The application will be assessed by the relevant Project Officer who will perform an eligibility check on all applications. This is mainly to check that the proposal fits the criteria of the call. All applications that pass this check will be subject to the review of an independent Scientific Review Committee (SRC). Once the SRC has reviewed the proposal and made its suggestions, the EDCTP Partnership Board (PB) will pass on their recommendations. The EDCTP Secretariat will then prepare a report of the recommendations to be forwarded to the EDCTP General Assembly (GA) before a decision making meeting, where the GA will make a final decision on whether or not to fund the application.
All proposals will be reviewed based on the following criteria:
- Excellence (feasibility, impact, innovation, quality and record of applicants, quality of the proposed set up)
- EDCTP relevance (public health relevance for developing countries, adequacy of proposal in context of the call)
- Partnerships (contribution to improved north-north, north-south, south-north and south-south collaboration)
- Project Management (representation of required expertise, appropriateness of budget).
Who will be on the Scientific Review Committee?
After receipt of the application the EDCTP Project Officer assigned to the call will identify potential External Referees and Scientific Review Committee members to review the application. Candidate reviewers are selected on the basis of their experience and appropriate range of competencies in pre-defined fields relevant to EDCTP, and need to be approved by the Partnership Board and the General Assembly. For each disease the EDCTP Secretariat will select an SRC consisting of four specialists and two generalists. Candidate reviewers can not be (co-)applicant in the application to be reviewed, and no constituency member can be a candidate reviewer in compliance with EDCTP Policy on Conflict of Interest.
Will I be given the opportunity to respond to referee comments?
The comments of the referees are sent anonymously to the applicants for them to respond in writing.
I would like to submit an application but I do not know how I can get cofunding. Who could help me and how can I apply for cofunding?
Applicants should contact their national European Networking Officer (representatives of the European national programmes, ENOs) through the contact ENO form on the EDCTP website. The ENO will be able to explain to the applicant the conditions under which cofunding may be available and provide them with the cofunding letters to EDCTP which are an eligibility requirement for all proposals. In each proposal, the eventual participation of at least two different EDCTP-EEIG Member States is required.
Could training materials be eligible as cofunding, i.e. contributions in kind?
Yes. Training activities, equipment, salaries of participating scientists, facilities and/or other existing resources are considered as in kind contributions. The relevant legal entities (Head of research centre, University etc) should mention the contributions and their value to the project in a letter that will be submitted with the application.
What is the expected duration of grants?
The grant duration is specified in the call text, but most grants run from 1 to 3 years, depending on the call, and the project. The maximum duration is 5 years only.
When will the awards be announced?
Once the EDCTP Project Officer determines that your proposal is eligible for review, a formal letter will be sent to you detailing the review procedure including the timelines and when you can expect to hear a decision.
When will funds be available?
Subject to agreement of the budget and signing of the contract by all parties, funding can be released. The funding is released in several parts, based on the research party meeting milestones in the agreed workplan. The research party must make reports on its funding at regular pre-designated intervals, and if the work is proceeding as planned, then the next payment can be made.
Is there any information available on the awarded projects?
EDCTP publishes monthly overviews of awards granted on its website, and has a public online database containing summaries of all EDCTP-funded projects. This Project Profiles database is searchable, and usually provides printable PDFs for each project.
