US Food and Drug Administration
Department of Health & Human Services
By: Beverly Corey, DVM
FDA and its partners in Sub-Saharan Africa have made great strides in improving the oversight of the clinical trials of medical products in development—an important advance in protecting public health in both the U.S. and Africa. This is important not only to protect the Africans who are participating in these tests of medical products, but also because the FDA and other regulatory authorities must rely on the results of these studies when reviewing marketing applications for the products.
FDA’s Office of International Programs (OIP) established its Sub-Saharan Africa Post in Pretoria, South Africa, in June 2011. We have been building regional relationships that allow us to share information about FDA policies and procedures, and to better understand the regulatory landscape there. The latter is no small feat in this vast region of 54 countries with varying degrees of regulatory strengths and capabilities.
However, our collaboration with the Southern Africa Development Community (SADC), which represents 15 African nations, has allowed FDA to strategically engage in strengthening regulatory capacity in the area of Good Clinical Practices (GCPs) and clinical trial inspections. These practices, and the inspections to ensure that they are followed, are designed to protect the integrity of data produced by the trial and the safety of its participants.
This activity has given expertise to regulators who did not think their knowledge base was extensive enough to audit (monitor) and inspect clinical trials. Regulators in countries that once did not audit clinical trials are now doing so. With more than 2,000 clinical trials being conducted in Africa—over half of them in South Africa—this is a momentous public health achievement. The Sub-Saharan Africa Post conducted a successful FDA/SADC Good Clinical Practice Inspection training from August 24-28, 2012, in Lusaka, Zambia. Thirty six drug regulators from 13 SADC countries participated, including Angola, Botswana, Lesotho, Malawi, Mauritius, Mozambique, Namibia, Seychelles, South Africa, Swaziland, Tanzania, Zambia and Zimbabwe.
This was the third in an FDA training series—typically offered in three to four phases—to develop trainers who have expertise in clinical practices and inspection. These individuals will also be prepared to train others within their agencies and the regulated community.
This particular workshop was designed to reinforce lessons learned and provide additional inspectional experience for those who completed workshops in the first two training phases in Botswana in 2010 and in Pretoria in 2011. The goals of Phase 3 include reviewing core knowledge and skills, preparing inspection reports and inspectional observations; acquiring additional mock inspection experience at clinical investigator sites; gaining experience with new types of study protocols; and promoting regional networking.
These countries continue to make substantial progress in the oversight of clinical trials. For example, at the onset of our first training, only three of 13 participating countries were involved in how clinical trials are conducted. We now have an additional two countries conducting oversight, with others poised to start soon. Other milestones from our training include important advances towards systematic oversight in Botswana, Mauritius, Swaziland, Tanzania, Zambia and Zimbabwe.
The definitive winner here is public health, both the health of the African people who participate in the trials and the health of the patients who may one day be taking these drugs being studied.
Beverly Corey, DVM, is the Senior Regional Advisor for Sub-Saharan Africa, FDA Office of International Programs, US Embassy, Pretoria, South Africa
No comments:
Post a Comment