FDA Seeks To Get Minorities More Involved in Clinical Trials

Posted on April 26, 2013

In a new report, the Food and Drug Administration explains how the agency is attempting to bolster the efficacy of clinical trials by pushing for more minorities to be involved with said trials.

Getting people of varying backgrounds and ethnicities into these trials is vital for drug makers looking to exhibit the safety and effectiveness of a product.  Without adequate representation, reactions that would affect a given demographic might not be properly demonstrated in trials as they should.

Genetics can play a critical role in how a person reacts to a drug and how susceptible an individual is to certain maladies.  The Office of Minority Health’s director explains that Hispanic individuals and African Americans are more at risk of things like obesity, heart disease, HIV, and diabetes.  Differences in genetic coding can also cause cancer treatment to be more toxic and blood pressure drugs and antidepressants to be less effective.

But despite these differences, underrepresentation is common.  Hispanics stand at around 16% of the country’s population yet only make up 1% of persons in clinical trials.  African Americans, which make up 12% of U.S. citizens, only make up 5% of trial participants.

The FDA Safety and Innovation Act from last year paves the way for efforts that can get minorities more involved in clinical trials so that demographic-specific issues might be addressed.  By July of this year, the FDA is tasked with reporting on current trends in order to improve representation in trials.  Until then, the agency advises that persons interested in clinical trials ask their doctors about availability.

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