A Patient First Approach to addressing Clinical Trials Inequities

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[co-author: David Gruber]

In an overview study of participants in the clinical trials of 35 novel cardiometabolic drugs (24 cardiovascular and 11 diabetes drugs) that were approved by the FDA from 2008 to 2017, the median number of trial participants was 5,930 — yet Black participants represented only 4% of trial enrollees. Consequently, the efficacy of these drugs in the Black population is unclear due to the significant underrepresentation in these studies.

In the clinical trial of Ninlaro, a cancer drug for multiple myeloma that was approved by the FDA in 2015, only 1.8% of trial participants (n=722) were Black — even though Blacks account for 20% of multiple myeloma patients. An analysis of cancer drugs approved since 2015 found less than 5% of the patients in 77.4% (24/31) of trials were Black. Only 6.5% of the trials (2/31) reached 10% Black enrollment. Similar disparities were shown in immunotherapy trials. As a result, Black Americans are not getting equal access to experimental cancer treatments.

Low enrollment may result from limited awareness of the trial, poor health literacy, financial (out-of-pocket costs) and logistical (distance from trial site) challenges, as well as mistrust, the latter related to the Tuskegee Syphilis Study and forced sterilization in segregated hospitals. Once enrolled, black participants tend to drop-out of trials at higher rates. Potential solutions are identified in the article. The National Institute of Health (NIH) has shown its possible to increase minority representation in clinical trials.

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