Evaluating the impact of clinical trials in Africa

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* This is a new call initiated by the EDCTP member states in order to gain more insight into the relationship between health services and clinical trials with the aim of promoting synergy and ensuring sustainability of health services. Funding for this call is provided by the Netherlands, UK, Sweden and Spain.

Description of the EDCTP grant schemes
The main objective of EDCTP is to support the development of new clinical interventions to fight HIV/AIDS, malaria and tuberculosis. This is achieved through; 

• Integration of Member States’ national programmes
• Strengthening of north-south partnership
• Coordination and networking of African researchers
• Establishing sustainable capacity building in Africa.

In order to realise these objectives EDCTP supports multinational, multicentre projects which combine clinical trials with capacity building and networking.

Purpose of this grant
There is anecdotal information that clinical trials may negatively impact routine healthcare delivery by diverting resources. Contrary reports, however, have indicated that clinical trials contribute to the quality of routine healthcare, for example, by providing training and improved infrastructure.

The purpose of this grant therefore, is to gain comprehensive insight into the impact of clinical trials on health services in sub-Saharan Africa, especially with regard to the quality of those services delivered to women and/or children.

Emphasis should be placed on evaluating the impact from the perspective of patients; health professionals; the community; and, public health services at the sites in sub-Saharan Africa, where the clinical trials are being conducted.

The project should be designed so that the outcome could contribute to the development of methods to further embed clinical research within the health services. This is important since it is the health services that that would eventually be responsible for implementing the (new) interventions resulting from the clinical trials.

This call offers consortia senior public health/social science researchers from Europe and sub-Saharan Africa the opportunity to apply for a 1-2 year research grant to investigate the impact of EDCTP and non-EDCTP funded clinical trials in sub-Saharan Africa.

General requirements and eligibility criteria

1. The proposed project(s) must involve at least two EDCTP-funded clinical trial sites
2. Applicants must be senior scientists affiliated with African institutions
3. The actual implementation of the research project can be delegated to an African student holding a Masters degree or be part of an ongoing PhD study
4. Proposals should be multidisciplinary incorporating issues such as clinical, social-economic and other public health perspectives
5. Proposals should evaluate the impact of clinical trials from qualitative and quantitative points of view
6. The project coordinator or principal investigator of the clinical trial site and head of the institution of the health services involved in the clinical trial being studied should confirm their willingness to cooperate in the research project. A signed letter from each site involved confirming this must be submitted along with the application
7. Proposals in which the project coordinator is a national of a sub-Saharan African country and/or based at an African institution are particularly encouraged
8. The results of the proposed project must be published both as scientific paper(s) in internationally recognized peer reviewed journals and as policy paper(s) directed at non-scientific stakeholders
9. The maximum budget allocated per project will be 250,000 euro
10. The duration of the proposed project should be between 1-2 years

Selection criteria
All proposals will be assessed based on the following criteria:

1. Project excellence (feasibility, innovation, quality and record of investigators, quality of methodology)
2. Potential impact (need for strengthening, restructuring existing research capacities, knowledge dissemination, sustainability)
3. Compliance with national and international standards of research, Good Clinical Practice, ethics and safety related issues (in accordance with EDCTP guidelines) where these apply.
4. Consortium description (appropriate expertise, excellene and balace of north-south collaboration).
5. Involvement of at least 2 named EDCTP-funded clinical trial sites in sub-Saharan Africa
6. Project Management (organisational structure, decision-making mechanisms, knowledge management)
7. Gender issues (promotion of gender equality, gender action plan concerning the staff involved in the project).

Administrative requirements

1. Proposals must be submitted before the deadline in pdf-format
2. Applications must be written in English
3. Participants in a proposal must be from publicly funded institutions from sub-Saharan African countries.
4. The project coordinator must be employed by a publicly funded institution from either an EDCTP-EEIG Member State or a sub-Saharan African country.

List of the 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, Sudan, Swaziland, Tanzania, Togo, Uganda, Zambia and Zimbabwe.

Intellectual Property Rights
EDCTP aims to ensure that any Investigational Product or its successors shall be accessible and available at an affordable price in developing countries. For more information please consult the EDCTP intellectual property rights policy available on our web site.

Legal information and support
EDCTP is supported by the Directorate General for Research of the European Commission, via Article 169 of the Treaty, decision No 1209/2003/EC of the European Parliament and of the Council of 16 June 2003.
EDCTP conforms to the legislation of The Netherlands concerning the Personal Data Protection Act.

Submission
In order to submit an application, please carefully refer to and make use of the following documents:

• Application form
• Budget form
• Guidelines for applicants
• Self-eligibility check form
• Call text (PDF)
  

Complete applications should be submitted electronically (via email) to: proposals[at]edctp.org.

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