By Alaric Debarment, MedCity News | July 7, 2019

Experts said the rise of cutting-edge new therapies highlighted disparities between clinical trial populations and the patients receiving new drugs. An FDA draft guidance earlier this month sought to address the issue.

The idea of a drug having to undergo clinical trials before becoming eligible for regulatory approval seems simple enough. But while dozens of drugs win approval every year from regulators like the Food and Drug Administration and European Medicines Agency, the studies that lead to their approval are often not demographically reflective of patients in the “real world.” And with the rise of precision medicine, targeted drugs and gene therapies, lack of diversity in clinical trials can make it more challenging to get a complete picture of a drug’s safety-efficacy profile.

On June 6, the FDA issued a draft guidance on how industry could increase diversity in clinical trial populations through trial design, adjusting eligibility criteria and improving enrollment practices. This would ensure that they better reflect the general population along racial, ethnic and gender lines. Experts are divided on how much real-world effect such guidance will have even as they laud the FDA for recognizing the importance of clinical trial diversity. 

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