by Stephanie Loomer, CISCRP Staff
Originally published in Clinical Leader. See link below for the complete article.
The importance of clinical trial research in developing treatments and advancing healthcare is widely acknowledged. In 2019 alone, 46,391 study volunteers contributed to clinical trials that resulted in the approval of 48 novel drugs. Of the demographic subpopulations represented, 9% of study volunteers were Black/African American, 9% were Asian, and 18% were Hispanic, highlighting a lack of representation of underserved populations.1 Recently, the FDA recommended broadening eligibility criteria to enhance diversity in clinical trials and therefore better reflect the patients who will be using a drug once it is approved.2
Pharmaceutical companies have begun working to address these disparities in clinical trials. For example, companies such as Sanofi and Eli Lilly have partnered with patient organizations and medical associations to better connect with underserved communities.3 When identifying study sites, both companies include geographic locations with diverse populations in their searches. Furthermore, Eli Lilly requires that at least two sites be in diverse locations for larger research studies.3 These are a few of the ways that companies can engage a more inclusive group of study volunteers and better understand how the drug will impact the broader target patient population upon approval.