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

Although the pharmaceutical industry acknowledges the necessity of enhanced diversity in clinical trials, there exists an ongoing discussion regarding the most effective approach. One point of consensus among life sciences professionals is that participation in clinical trials does not accurately mirror the demographic composition of the overall population.

As per the U.S. census data from 2021, ethnic and racial minorities constituted over 40% of the population. From 2015 to 2019, statistics from the U.S. Food and Drug Administration (FDA) reveal that these groups were noticeably underrepresented in clinical trials.

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.

To address regulatory, professional, and ethical aspects in clinical trials, learn why diversity must be taken into consideration during a study’s planning and recruitment phases.