What is European & Development Countries Clinical Trials Partnerships (EDCTP)?
The European & Developing Countries Clinical Trials Partnership (EDCTP) is a partnership of 14 EU countries, Switzerland and Norway, and 47 sub-Saharan African countries, which aims to establish a research and development programme for the development of new or improved clinical interventions to combat HIV/AIDS, tuberculosis and malaria through a long-term partnership between Europe and sub-Saharan Africa.
What are the main objectives of EDCTP?
The main objectives of EDCTP are:
- Acceleration of the development of new or improved clinical interventions, in particular drugs, microbicides and vaccines to fight HIV/AIDS, tuberculosis and malaria in sub-Saharan Africa through conducting and supporting clinical trials especially phases II and III
- Increasing African research capacity to tackle these diseases
- Supporting and facilitating the integration of the national health research programmes of the European Member States
- Strengthening of the related research and development capacity in sub-Saharan Africa. This includes fostering an enabling environment for best practice, including 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 185 of the Lisbon Treaty (ex Article 169 TEC).
What does Article 185 stand for?
Article 185 (ex. Article 169) of the Lisbon 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 185. The originality of Article 185 is related to the fact that the initiative comes from the interest and commitment of the Member States.
What is the main difference between EDCTP and other research programmes in the field of HIV/AIDS, tuberculosis and malaria?
EDCTP is the first joint programme to bring together the efforts of European Member States aimed at developing and evaluating new and improved drugs vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria. It is an organisation which facilitates coordination and integration of European Member States research activities in collaboration with their developing countries counterparts.
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:
- In 2009, an estimated 33 million people were living with HIV-infection globally, and 23 million of these were from Africa. In 2010, 1.3 million people were newly infected in Africa accounting for 50% of the 2.6 million global new cases
- More than 1.5 million people become infected with tuberculosis 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.
Given the scale of the problem, there is great urgency to increase research expenditure in sub-Saharan Africa to address the treatment gap. It is possible that the scope of EDCTP may expand in the future to include other developing countries outside of sub-Saharan Africa.
Do you also fund projects based in more developing countries other than sub-Saharan African countries?
No. 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. Below is the list of EDCTP-EEIG Member States and sub-Saharan African countries:
List of EDCTP-EEIG member states:
Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.
List of sub-Saharan African countries:
Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Democratic Republic of Congo, Republic of Congo, Ivory Coast, Equatorial Guinea, Eritrea, Ethiopia, Gabon, the Gambia, Ghana, Guinea, Guinea-Bissau, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Somalia, South Africa, South Sudan, Sudan, Swaziland, Tanzania, Togo, Uganda, Zambia and Zimbabwe.
What is the overall budget of EDCTP, and how will it be allocated?
The overall budget of EDCTP is around € 400 M from its inception in 2003 up to the end of May 2015. This budget consists of two components. The financial contribution of the European Commission is € 200 M. The national contributions of the Member States is estimated to be at least € 200M. 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 the EDCTP news alert.
What types of grants does EDCTP offer?
EDCTP offers grants that focus on clinical trials (which is the principal function of EDCTP) as the core and use networking and capacity development to build a sustainable environment for conducting high-quality medical research in sub-Saharan Africa. The grants 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 and regulatory capacity, Member States Initiated projects 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 proposal fits the call text requirements. Applications must be submitted via eligible institutions in sub-Saharan Africa or from European Member States. Depending on the particular Call for Proposals, there may be a requirement for applications to involve a minimum of two European countries and one or more African institutions. The European Member States are responsible for cofunding the project, providing at least 50% of the estimated financial resources required to carry out the project.
Applicants should submit their completed application (using the form and following the guidance notes for the particular call) to the EDCTP Secretariat via email (proposals[at]edctp.org). Applications must be received by the published deadline.
Are you open to prospective proposals at any time of the year?
No. EDCTP can only consider applications that are submitted in response to a specific call for proposals.
Who can apply for EDCTP funding?
Applicants based at eligible institutions in sub-Saharan Africa or in European Member States may apply for EDCTP funding in compliance with call specific terms and conditions. All calls are published with guidelines for applications.
How do I submit an application?
If your proposal is suitable for a particular callm download the application form, complete it and email it to proposals[at]edctp.org before the deadline.
Is there a limit to the number of applications I can submit?
To comply with Good Clinical Practice guidelines regarding time commitment to projects, Project Coordinators (PC) are advised not to submit more than one application. However, Project Coordinators may be involved as co-applicants (e.g. second or third named applicant) or collaborators on more than one application, subject to them being able to demonstrate sufficient commitment to a project.
How are application assessed?
First, an EDCTP Project Officer performs an eligibility check on all applications. This step ensures that the proposal fits the criteria of the call and that all of the required information has been provided. All applications that pass this check will be evaluated by a Scientific Review Committee (SRC) composed of independent experts. The SRC submits its recommendations to the EDCTP Partnership Board (PB) which considers the recommendations in the context of the EDCTP strategy. The PB, in turn, passes on its recommendations to the EDCTP General Assembly (GA). The GA approves the final awards. All proposals are reviewed according to the following criteria:
- Excellence (feasibility, impact, innovation, quality and record of applicants, quality of the proposed set up)
- Relevant relevance to EDCTP (public health relevance for developing countries, adequacy of proposal in context of the call)
- Partnerships (contribution to improved north-north, north-south and south-south collaboration)
- Project Management (required expertise and appropriateness of budget).
Who is the Scientific Review Committee?
After receipt of the application the EDCTP Secretariat identifies potential External Referees and Scientific Review Committee members to review the applications. Candidate reviewers are selected on the basis of their experience and scientific expertise. EDCTP has a policy in place to avoid conflict of interest during the review process EDCTP Policy on Conflict of Interest.
Will I be given the opportunity to respond to reviewers' comments?
Depending on the particular call for proposals, you may be given the opportunity to respond to anonymised extracts of the reviewers' comments as part of the application process.
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 Deputy GA member (representatives of the European national programmes, DGA) through the contact DGA form on the EDCTP website. The DGA 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. For certain EDCTP grant schemes, participation of two or more EDCTP-EEIG Member States is required.
What activities can be considered as cofunding, i.e. contributions in-kind?
Training activities, equipment, salaries of participating scientists, facilities and/or other existing resources may be considered as in-kind contributions. The relevant legal entities (Head of Research Centre, University etc) should describe the contributions and attribute their value to the project in a formal letter submitted with the application.
When are awards announced?
Once your proposal is deemed eligible for review, a formal letter will be sent to you setting out the review procedure including the timelines. The final outcome for all awards is communicated by letter from the Secretariat to the applicants following approval of awards by the EDCTP General Assembly.
When will funds be made available following a successful application?
Subject to agreement of the budget and signing of the contract by all parties, funding can be released. The funding is released on an annual basis, subject to the grant holder meeting the project milestones as set out in the agreed work plan. Grant holders are required to submit annual technical and financial progress reports prior to the release of funds on the grant.
Where can I find out more about awarded projects?
EDCTP publishes overviews of awards on its website, and has a public online database containing summaries of all EDCTP-funded projects. This Project Profiles database is searchable.