14 Feb Perseverance leads to progress

Now is the time to keep all stakeholders engaged in DEI in clinical research.

By Susan Landis, The Association of Clinical Research Professionals (ACRP)

This will be a critical year for professionals throughout the clinical research enterprise to build on the momentum gained in 2023 for improving diversity, equity, and inclusion (DEI)—not just among the volunteer participants in clinical trials, but also among all other stakeholders in their design, management, and results. 

In January alone, the U.S. Food and Drug Administration (FDA) released its Draft Guidance on the Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products. In addition, the National Academy of Sciences announced an important upcoming public workshop, titled Toward a Framework to Improve Diversity and Inclusion in Clinical Trials. This workshop builds upon previous meetings hosted by the Clinical Trials Transformation Initiative in June 2023, the Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women’s Hospital and Harvard in September 2023, and the FasterCures Center of the Milken Institute in November 2023. 

Further, on Capitol Hill in late January, U.S. Reps. Mike Kelly (R-Pa.) and Chrissy Houlahan (D-Pa.) introduced the Harley Jacobsen Clinical Trial Participant Income Exemption Act, legislation that aims to exempt all payments received by participants in clinical trials from being counted toward their gross income. A former member of the Association Board of Trustees for ACRP, Jennifer Byrne, and her team at Javara were among the original signatories to the letter. This is a big step in the right direction. 

So many in our industry are taking the right steps with great hope that our perseverance is leading to progress. With this in mind, I reached out to Stacey Bledsoe, MSN, Head of Global Clinical Trial Diversity & Inclusion at Gilead, whom I had the pleasure of meeting this year and hearing speak at several forums on issues tied to DEI. What better time than at the precipice of a new year to check in on this crucial topic and wonder aloud if our collective perseverance is leading to progress. Read more …