Racial disparities persist in genitourinary clinical trials of new biologic drugs and PET imaging radiotracers, according to a study published April 13 in Current Problems in Cancer.
Researchers at the University of North Carolina in Chapel Hill found significant disparities in nine clinical trials between 2015 and 2020 that led to U.S. Food and Drug Administration (FDA) approvals -- namely, that most study participants were white. The findings show how little has changed since the National Institutes of Health Revitalization Act was passed in 1993, wrote lead author Dr. Asia Matthew-Onabanjo, PhD, and colleagues.
"Nearly 30 years later, our results highlight the struggle to achieve adequate racial and ethnic representation in clinical trials research," the group wrote.
Clinical trials are necessary to investigate the efficacy and safety of novel therapeutics. Yet racial disparities among participants ultimately calls into question how well new drugs or imaging agents may work for the general population, as racial backgrounds have been shown to influence drug response, treatment outcomes, as well as side effects, the group wrote.
To explore these disparities, the researchers focused on clinical trials that led to FDA approvals between 2015 and 2020. The trials tested three biologic drugs for prostate cancer, two cancer PET imaging tracers (Ga-68 PSMA-11 and F-18 fluciclovine), and four new biologics for the treatment of urothelial cancer.
Matthew-Onabanjo and colleagues found that in prostate cancer trials including 5,202 participants, 69.8% were white, 4.0% Black, 11.0% Asian, 3.6% Hispanic, and less than 1% were American Indian/Alaska Native or Native Hawaiian/Pacific Islander.
They also found that, in urothelial cancer trials which included 704 participants, 75.1% were male, 80.8% were white, 2.3% Black, 2.4% Hispanic, and less than 1% American Indian/Alaska Native or Native Hawaiian/Pacific Islander.
"The underrepresentation of racial and ethnic minority groups in these [clinical] trials is discordant with the current population as well as the population of the disease prevalence, and may not accurately reflect drug responsiveness in those populations despite FDA approval," they wrote.
For instance, the authors noted that Black men are 70% to 80% more likely to be diagnosed with prostate cancer and up to two-and-a-half times more likely to die from the disease than white men.
Despite efforts such as the NIH Revitalization Act of 1993 and more recent initiatives mandating the inclusion of women and minorities in clinical research, more work needs to be done, the authors wrote.
"Involving stakeholders who represent the needs and interests of underrepresented populations in the design and implementation of clinical trials of novel agents may be a strategy to increase diversity, equity, and inclusion among genitourinary clinical trials," they concluded.
