The Need For Better Diversity Data In Clinical Trial Benchmarking & Feasibility

The availability of demographic data — and using it to inform future research — is key to improving representation and reducing inequities in clinical trials. However, sponsors face challenges in obtaining clinical trial diversity data. When such data points do exist, regulatory agencies must make them readily available, and sponsors need easy access.

In recognizing the importance of diversity in clinical trials, there has been an ongoing discussion amongst those in the life science industry regarding the most effective approach to overcoming these challenges. However, the consensus among life sciences professionals remains that the representation in clinical trials does not reflect the demographic composition of the overall population. Data from the U.S. census in 2021 reveals that ethnic and racial minorities accounted for more than 40% of the population, yet statistics from the U.S. Food and Drug Administration (FDA) indicate a clear underrepresentation of these groups in clinical trials between 2015 and 2019.

To truly make an impact in representing all demographics in clinical research, it is crucial to consider diversity during the planning and recruitment phases of a study, rather than solely analyzing it retrospectively. Learn how by addressing the regulatory, professional, and ethical aspects associated with diversity from the early stages, the industry can effectively reverse existing trends and ensure meaningful inclusion in clinical trials.