Much of the contemporary discussions on racial representation and minority empowerment have been focused on increased participation in politics, higher education, and the workforce. A facet that warrants increased public scrutiny is the lack of minority representation in randomized clinical trials, which plays a critical role in perpetuating health inequities. Today’s clinical trials fail to represent the rich diversity of this country, which effectively tailor promising treatment options to non-Hispanic whites due to study over-representation.
In 2012-2016, non-Hispanic blacks were 2.2 times more likely to die from prostate cancer than non-Hispanic whites. Despite their heightened risk, non-Hispanic blacks, with Latinos and Asian-American men, continue to be underrepresented in Phase III prostate cancer trials. By ensuring that participants in clinical trials represent at-risk populations, we are maximizing these studies’ external validity to ensure that the results are generalizable across racial subgroups. Minority participation in Phase III trials is particularly crucial as Phase III results usually determine drug efficacy.
Currently, the US Food and Drug Agency (FDA) and the National Institutes of Health (NIH) are the two primary federal agencies involved in increasing minority recruitment for clinical trials. In 1993, the NIH Revitalization Act was signed into law to require NIH-funded clinical trials to include women and minorities. The law’s primary goal is to collect more data on minority health outcomes by requiring study investigators to report subgroup health outcomes.
Due to the lack of regulatory oversight, however, regulatory compliance on reporting health outcomes by race or ethnicity remains a critical challenge. A recent study has found that only 13.4% of the NIH-funded trials performed the required subgroup analysis as mandated by the 1993 law. The proportion of NIH-funded clinical trials has also dropped from 12.9% in 2006 to 6.0% in 2014. Due to this observed shift away from NIH funding, it is increasingly crucial for the FDA to take a more proactive role in addressing racial misrepresentation in clinical trials.
Last year, the FDA drafted its non-binding recommendations for trial sponsors to tackle racial inequities by calling for several policies, including a call to relax eligibility criteria for trial participation. Due to other health inequities within our system, minority patients are generally sicker than non-Hispanic whites, making them more likely to be excluded from clinical trials.
There is a dire need for a more proactive FDA and NIH to address racial misrepresentations in clinical trials more forcefully. As a start, the NIH should perform its oversight obligations to ensure that study sponsors follow the law. Given the lack of racial subgroup analyses in clinical trials, the FDA should increasingly scrutinize trial results before drug approval to promote patient safety.
The lack of diversity is both a moral and medical issue that warrants a more forceful response from the federal government. We deserve better.
Josemari Feliciano MPH is a student at the Yale School of Public Health.