top of page

Rubix LS Applauds FDA Draft Guidance Calling for Enhanced Clinical Trial Diversity

“The moral, scientific, and business cases for promoting diversity in clinical trials have never been clearer,” says Reginald Swift, Ph. D, founder/CEO at Rubix Life Sciences. “It’s time to truly promote clinical trial diversity by harnessing data and working with experts who understand cultural nuances, especially for traditionally underserved patient populations.”

Diverse patient populations translate into more effective trials and generate richer and more useful data, Swift notes. He cheers a recent initiative from the U.S. Food and Drug Administration, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry.”

The Draft April 2022 guidance specifically calls for increased representation in clinical trials of Black or African American, Hispanic/Latino, Indigenous and Native American, Asian, Native Hawaiian, and Other Pacific Islanders, and other persons of color.

FDA calls on regulated clinical trial entities to include a Race and Diversity Ethnicity Diversity Plan. “FDA will evaluate [it] as an important part of the sponsor’s development program,” the agency says in the new guidance.

However, diversity efforts risk falling short of their tangible goals if patients and their healthcare journey aren’t front and center when trials and related diversity programs are being developed, Swift says.

“It is vital for scientists, engineers, researchers, doctors, designers, regulatory and business strategists to understand individual patients to most effectively harness the richest data and intelligence to create optimal trial results and get the most effective drugs and treatments to the most patients possible,” Swift says.

“Whether it is overcoming the mistrust of clinical trials because of historical abuses, or a lack of understanding about how clinical trials are conducted and their high bar for safety, sponsors and others need to genuinely connect on a grassroots level with specific patient populations if they truly want to widen the patient participation net,” Swift says.

Building on the FDA’s latest actions, and avowed goal of increasing diversity in the clinical trial patient population, Swift notes, “We share a collective commitment to advancing treatments and improving patient outcomes. Promoting diversity is a vital foundation for these efforts. It’s time for us to come together and help deliver on the full promise of clinical trials for all Americans.”

For more information, LINK to Rubix & FDA Diversity in Clinical Trials

1 view
bottom of page