The U.S. Food and Drug Administration recently announced a new requirement for researchers and companies to submit a plan for ensuring diversity among clinical trial participants. At FSG, we’ve been working with life science companies on health equity strategies for several years, and we’re excited to see this announcement taking us one step closer to standardizing a more expansive approach to how clinical trials are conducted.

We know that ensuring people from diverse backgrounds are represented in clinical trials is key to advancing health equity. When researchers fail to enroll a diverse study population in clinical trials, they are prevented from gaining a thorough understanding of how new drugs and medical products will work for a range of patient populations. Non-white communities make up nearly 40% of the U.S., but their inclusion rate in clinical trials ranges from 2% to 16%. This costs companies when therapeutics’ safety and efficacy information is not fully generalizable and results in lost revenue from not reaching historically underserved populations.

We’re thrilled to see this announcement from the FDA, which supports more life science companies making progress towards diversity in clinical trials as part of their broader commitments to health equity. As Dr. Thomas Hwang, a physician at the Dana-Farber Cancer Institute, pointed out in a Nature journal article, “This is the biggest change in the regulatory landscape for clinical-trial diversity in the last three decades.”

Life science companies can prepare for these new requirements now by taking additional steps to build more inclusive research and development (R&D) processes and integrate a health equity lens throughout their entire product lifecycle.

Read the full article about clinical trial diversity by Lolita Castrique-Meier and Nikhil Bumb at FSG.