Summary of When Will Clinical Trials Finally Reflect Diversity?

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When Will Clinical Trials Finally Reflect Diversity? summary
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You seek treatment for a health condition, and your doctor writes you a prescription. But will the drug be safe for you? If you are a racial or ethnic minority, or have a rare genetic variant, chances are that what works for others will be ineffective or even dangerous for you. The term “others” in this case refers to clinical trial participants who continue to be predominantly white, as Todd C. Knepper and Howard L. McLeod explain in the journal Nature. Their article makes a compelling case for diversifying clinical trials and will engage anyone concerned with science, health care and society as a whole. 

About the Authors

Todd C. Knepper is a personalized medicine specialist and Howard L. McLeod is chair of the Department of Individualized Cancer Medicine at DeBartolo Family Personalized Medicine Institute in Tampa, Florida. 

 

Summary

Clinical trials have too little racial and ethnic diversity.

Over the past two decades, the US Food and Drug Administration (FDA) has almost doubled the number of countries participating in clinical trials. Yet the clinical trial population has not become more diverse. In 2014, 86% of trial participants were white. Whites are thus disproportionately overrepresented.

In the United States in 2014, non-Hispanic whites made up only 62% of the population. Given that many countries around the world follow the FDA’s lead in approving new drugs, the lack of diversity among trial participants is even more problematic. In 2015, 75% of the world’s population was either African or Asian.

The effectiveness and side effects of drugs vary...


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