Clinical Trial Diversity—Will We Know It When We See It?

Abstract

This Editorial discusses the existing policy efforts in the US for ensuring adequate racial and ethnic diversity in clinical trials, identifies barriers to consistency and acceptable representation, and suggests measures to address them.

Incorporating Real-World Clinico-Genomic Insights to Inform Diversity Enrollment Targets in Oncology Trials

“…The FDA’s draft guideline on diversity plans suggests that enrollment goals should reflect the epidemiology of the targeted disease. 5,17 In our example, the question arises: Is the disease being treated prostate adenocarcinoma, or specifically TMPRSS2:ERG+ prostate cancer? It has been suggested that early-onset metastatic and clinically advanced prostate cancer, characterized by a higher incidence of TMPRSS2:ERG fusions, is a distinct clinical and molecular entity.…”

“…However, this does not guarantee that the final numbers of patients enrolled from different groups will allow for sufficiently powered subgroup analyses. 17 If such analyses are desired, it may be necessary to supplement minority groups based on power calculations.…”

“…10 However, a number of issues create challenges for effectively leveraging RWD for this purpose, such as the overrepresentation of insured and White patients, 11 significant non-random missingness in R/E data, [12][13][14][15][16] and inconsistencies between RWD and disease incidence databases. 17 These hurdles often reflect broader issues of healthcare access and socioeconomic disparities. 18 Additionally, R/E data in RWD may originate from various sources, not exclusively self-identified R/E, but also includes the assignment of R/E classifications on patients by third parties.…”