FDA: Blacks More Accurately Reflected in Trials, But Other Races Still Underrepresented
Efforts to improve diversity in research appear to be paying off for Black Americans, but other minorities still aren’t being adequately represented in trials, a new FDA analysis shows.
The analysis assessed 517 trials from snapshots published between 2015-2019 and identified 102,596 participants from U.S. sites, about one-third of the nearly 293,000 total global participants in the trials.
The good news is that the proportion of Black/African American trial participants ranged from 15 to 19 percent (16.3 percent on average) in those years, annual participation rates that were consistently at or above U.S. Census numbers that estimated them at 13.4 percent of the population, on average, in the same timeframe.
The analysis was done by FDA’s Acting Commissioner Janet Woodcock and other staff in the agency’s Office of the Commissioner and the Center for Biologics Evaluation and Research, including Richardae Araojo, associate commissioner for minority health and director of the Office of Minority Health and Health Equity.
But while Blacks appeared to be more accurately represented in clinical trials in relation to their makeup of the U.S. population, the same couldn’t be said for the other groups. Latino participation ranged from 10 percent to 21 percent, or 15.3 percent on average, and failed to surpass or meet Census levels (18.5 percent on average) in three of the five years.
Asian participants ranged from 2 to 3 percent compared to their average Census rate of 5.9 percent, and American Indian/Alaska Native participants saw a dismal 0.52 percent on average compared to their 1.3 percent Census average. Neither of the groups exceeded or matched their Census estimates in any year.
“Although comparing participation in clinical trials by racial and ethnic groups with the Census alone is not a definitive assessment, the low proportions of some racial and ethnic groups in these data highlight the need to increase diversity in clinical trial participation in the U.S.,” the authors said. “In this study, the mean and yearly participation rates were at or above the U.S. Census level for Black or African American populations but not for other racial or ethnic minority groups.”
The study, the authors noted, was confined to five years’ worth of data from new molecular entity and original biologics trials and the data they analyzed weren’t always complete, with approximately 7 percent to 13 percent of ethnicity data not present.
Further research is needed on the subject of diversity, the authors said, calling for a study comparing trial participation based on disease prevalence and epidemiology to paint a more detailed picture of racial representation in clinical trials.
Phesi also recently analyzed a decade’s worth of protocol data spanning approximately 1.3 million patients in phase 2 and 3 trials. They came to the same conclusion: Black patients became better represented, while Hispanic/Latino, Asian, Native Americans, Alaska Natives and other Pacific Island patient subpopulations still saw significant underrepresentation.
“Patient subgroups in clinical trials continue to evolve as availability of real-world data allows sponsors to design more precise and targeted trials. The demand for inclusion also extends into other characteristics like sex and age,” Paul Chew, Phesi’s chief medical officer, said.
Pharma giant Pfizer also evaluated the diversity of its clinical trials this year, publishing an analysis of 213 interventional trials that enrolled 103,103 U.S. participants between 2011 through 2020. The company found that 56.1 percent and 51.4 percent of its trials enrolled levels of Black/African American participants and White participants, respectively, above Census rates. Similarly, 52.3 percent of its trials enrolled numbers of Hispanic or Latino participants above their Census numbers. But only a small proportion of its trials were representative of the Asian (16 percent), Native Hawaiian/Pacific Islander (14.2 percent) and American Indian/Alaska Native (8.5 percent) populations in the U.S.
Access the JAMA article here: https://bit.ly/3dyhrEc.