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Clinical Trial Diversity-Africa in Focus!

Emmanuel

Updated: Nov 1, 2022

Clinical trials are necessary to determine the safety and efficacy of new investigational products in all patient populations.

Race, ethnicity, age, and sex can all impact how different people respond to the same medicine or vaccine. This is why diversity among clinical trial participants is so important. The more diverse a group of clinical trial participants is, the more we can learn about the safety and efficacy of a potential medicine or vaccine for people now and in the future.


Patients of African descent are under-represented in clinical trials even though they experience a disproportionate share of mortality in United States and Africa.

The efficacy of standard-of-care drugs in African patients, and patients of African ancestry more broadly, has not been studied adequately. In the United States, where 20% to 25% of participants in global clinical trials are enrolled, only 2%-4% of participants are of African descent. Less than 1% of international trials submitted to the US Food and Drug Administration (FDA) for approval of drugs enroll participants from clinical sites in Africa. Most trials that do enroll patients in sub-Saharan Africa typically focus on post-marketing surveillance. The lack of inclusion in registration trials of participants either from Africa or of African descent likely contribute to greater rates of treatment failure and poorer outcomes in African patients. Partnerships between African and international stakeholders are critical to expanding high-quality clinical trial activities in Africa. Successful multidisciplinary HIV/AIDS research and clinical care collaborations in African countries—in which robust prevention and treatment programming led to a significant decline in HIV incidence—can serve as models.



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