AfroGuide: Putting Africa on the Clinical Trials Map

June 1, 2008

Applied Clinical Trials

Volume 0, Issue 0

A new project focuses on developing Africa's legal and regulatory framework for health research.

The UN Economic Commission for Africa (UNECA) and the African Union's (AU) conference Science with Africa, which took place March 3–7 in Addis Ababa, Ethiopia, saw an eventful roundtable discussion on that launched the AfroGuide Project: Developing Guidelines for Health Research in Africa. The roundtable, comprised of more than 70 international health research and bioethics experts and policy makers, focused on a plan to develop the legal and regulatory foundations for best practices in African clinical trials and other health research endeavors. The UNECA and AU invited the Good Clinical Practice Alliance–Europe (GCPA; Brussels, Belgium) to develop the initial proposal and coordinate the project.

The roundtable participants at "Science with Africa" pause their discussion of the AfroGuide Project to take a photo.

"The project's mission is to promote the development and implementation of the highest scientific and ethical standards for clinical trials at the continental, national, and local levels in Africa," said Francis P. Crawley* to Applied Clinical Trials. "The overall aim...is to provide a harmonized approach across Africa for clinical trials and medicines development. This is carried out within an overall project vision of a collective African and international engagement through clinical trials focused on improving medicines and health care in Africa."

Crawley elaborated further, citing some of the background that paved the way for the initiative. "The AfroGuide Project is being developed alongside the ongoing work by the African Union's project, carried out by the Health Ministers, on drawing up a Pharmaceutical Manufacturing Plan for Africa, initiated in Abuja, Nigeria, in January 2005. Up until present, African countries have largely depended on imported drugs, both generic and proprietary." Since African countries are disproportionately affected by a number of diseases—such as HIV and malaria—it is crucial that Africa build regulatory, scientific, and ethical infrastructures that allow the continent to conduct clinical trials and develop new drugs.

Roundtable experts cited previous experiences in African countries to serve as a basis for creating standards in such areas as ethical review, genetics, GCP, and informed consent. "These experts are now engaged in identifying existing standards and practices across the African continent based on national and international laws and guidances," Crawley explained. "A dialogue with the health and political authorities across Africa is also being undertaken by the experts and the pan-African organizations supporting the project." Ultimately, the participants agreed that Africa must establish its own guidelines, laws, and regulatory frameworks to improve health research.

"Specific achievement targets will be set at the national and pan-African levels that will guide the focus, timelines, and outcomes of the project," said Crawley. "A great deal of assistance is needed to achieve this ambitious project, both from within Africa and from the larger international community."

Thus, the Cameroon Bioethics Society—the African project secretariat—and the GCPA, the international secretariat, will help coordinate the African and international partners and develop a strategic plan based on a GCPA proposal.

A Project Committee meeting is slated for July 2008 at the United Nation's Conference Center in Addis Ababa, Ethiopia, and additional workshops will be held in the upcoming months. There is much work to do, but the importance of treatment and public health benefits brought by clinical trials to Africa cannot be over-estimated.

"Without the development of robust regulatory frameworks and sound practices, the investment of the pharmaceutical industry and international community in medicines development within Africa will remain marginal and the health of individual Kenyans, Congolese, South Africans, and Moroccans will continue to pay the cost," observed Crawley. "The AfroGuide Project requires widespread input and support from individuals and organizations with an interest in developing clinical trials in Africa. Applied Clinical Trials has helped to open up this discussion on standards for health research around the world, including Africa. We hope the readers of [Applied Clinical Trials] will consider assisting in the development of the AfroGuide Project."

If you are interested in getting involved with the AfroGuide Project, please contact Francis Crawley at fpc@gcpalliance.org—Samantha Etkin

*Francis P. Crawley is also a member of the Applied Clinical Trials Editorial Advisory Board.