The FDA Wants to Improve Diversity in Its Clinical Trials

Photograph by luchschen via iStock.

In a release sent out on January 10, the US Food & Drug Administration (FDA) announced that it is “encouraging more peopleincluding members of diverse racial and ethnic groups, women, and older adultsto participate in clinical trials.” According to the release, not very many people sign up to participate in their trials, and the pool of people they have been able to pull “don’t always represent the US population.”

Conducting clinical trials with a diverse set of people is important, especially as the FDA states that certain groups of people can be more liable to develop diseases than others. Though the FDA received a lot of backlash over the drug BiDil, which was supposed to work better in African Americans than in Caucasians, it’s important for those who prescribe drugs to know whether medications differ in effectiveness for different parts of the population.

This isn’t the first time the FDA has considered the relationship between ethnicity and medications. In 2008, FDA researchers produced a study that examined how people of different ethnicities may require different dosages for certain drugs. The study gives the example of warfarin, which is used to treat blood clots, stating that it’s been found that African Americans require higher doses of it than Caucasians or Asians. Of course, varied reactions to medications are based in differences in genetics, not race, which is why the FDA isn’t just looking for diversity of ethnicities, but also in regard to age and gender—and just more participants overall—in their clinical trials.

“There are biological differences in how people process drugs. For example, variations in genetic coding can make a cancer treatment more toxic in one ethnic group than it would be in another,” says FDA spokesperson Lauren Smith Dyer. “These variations can make also make drugs like antidepressants and blood-pressure medications less effective in one group than another. Getting more data on these differences is essential for the FDA to truly know that a medical product will truly work and be safe for all patients.”

As the FDA seeks more participants for trials, it currently has a section on its website where interested participants can find out more about the clinical trial process, and has stated it is “working with a variety of stakeholders, including federal partners, medical product manufacturers, medical professionals, and health advocates” to increase diversity of their clinical trials.

“Medical products are safer and more effective for everyone when clinical research includes diverse populations,” says Smith Dyer. “Ensuring meaningful representation of minorities in clinical trials for regulated medical products is fundamental to the FDA’s regulatory mission and public health.”

Update: This article previously misspelled Lauren Smith Dyer as Laura Smith Dyer. 

Associate Editor

Caroline Cunningham joined Washingtonian in 2014 after moving to the DC area from Cincinnati, where she interned and freelanced for Cincinnati Magazine and worked in content marketing. She currently resides in College Park.