U.S. racial and ethnic participation in global clinical trials by therapeutic areas

Abstract

What is known and objective The discussion about health equity in the United States frequently involves concerns over racial and ethnic minority under‐representation in clinical trials and particularly in trials conducted in support of product approvals. The FDA has long worked to encourage diverse participation in clinical trials and through its Drug Trials Snapshots (DTS) program, the U.S. Food and Drug Administration (FDA) has moved to make trial demographic data more accessible and transparent. We conducted a demographic study of U.S. participants in clinical trials for FDA‐approved new drugs (new molecular entities [NMEs], and original Biologics License Applications [BLAs]) from 2015 to 2019, as reported in DTS database with a purpose of understanding the extent to which U.S.‐based trials used to support product approvals represent the racial and ethnic diversity of the U.S. population by therapeutic area. Methods Participant‐level trial data were collected by accessing the FDA electronic common technical document (eCTD), for the applications used to publish each Snapshot. The therapeutic area (TA) for each drug was determined by review division assignment. The demographic data were analysed and compared to U.S. census data. Results and discussion We examined 102,596 U.S. participants in trials of new drugs that were approved and presented in Drug Trials Snapshots between 2015 and 2019. White participation ranged from 51% in psychiatric trials to 90% in cardiovascular (CV) trials; Black or African American participation ranged from 5% in medical imaging to 45% in psychiatric trials; Asian participation ranged from 0.75% in CV to 4% in dermatologic trials; and Hispanic or Latino participation ranged from 1% in medical imaging to 22% in infectious diseases and gastroenterology trials. What is new and conclusion Our data showed variable representation of racial and ethnic minorities across therapeutic areas at the U.S. sites. Blacks or African Americans were represented at or above U.S. census estimates across most therapeutic areas, while Asians and American Indian or Alaska Natives were consistently underrepresented. Hispanic or Latino participation across most therapeutic areas was below U.S. census estimates, however, more variable, and a sizable proportion of data was missing. The next step is a comparison of trial participation based on disease prevalence and epidemiology, which is a more accurate assessment of trial diversity.

Recruitment of diverse community health center patients in a pragmatic weight gain prevention trial

“…18 Hispanic/Latino adults and/or those who speak Spanish are among the most underrepresented groups in clinical trials. 19,20 In fact, oftentimes, trial protocols exclude individuals who speak Spanish and/or do not provide clinical trial materials in Spanish. 21,22 Despite these barriers to clinical trial enrollment that often lead to underrepresentation of Hispanic/Latino adults, previous research indicates that they are as willing to participate in research as their non-Hispanic White counterparts.…”

“…Hispanic/Latino adults and/or those who speak Spanish are among the most underrepresented groups in clinical trials [19,20]. In fact, oftentimes, trial protocols exclude individuals who speak Spanish and/or do not provide clinical trial materials in Spanish [21,22].…”

The Importance of Diversity and Inclusion in Drug Development and Clinical Trial Conduct

“…1 While Black or African American participants made up 14% of the total participants enrolled in the neurology trials, Asians, Native Americans or Alaska Natives, and Hispanics or Latinos were well below the 2015 census rates. 1 In fact, Asians were consistently underrepresented in trials across all 13 therapeutic areas, ranging from only 1% to 4%. 1 It should be noted that all racial and ethnic minorities were underrepresented in oncology and hematology trials.…”

“…1 In fact, Asians were consistently underrepresented in trials across all 13 therapeutic areas, ranging from only 1% to 4%. 1 It should be noted that all racial and ethnic minorities were underrepresented in oncology and hematology trials. Underrepresentation remains a significant concern considering minority populations are more likely to be diagnosed with certain cancers and are more likely to die prematurely than White individuals.…”

Charting a Path Towards Asian American Cancer Health Equity: A Way Forward

“…However, the regrettable national policy excluding Asian Americans as an Underrepresented Minority, perpetuation of the model health minority myth associated with Asian Americans, and failure to consider the unique, unusual, and unnecessary cancer burden confronting rapidly-growing, distinct Asian American subgroups contribute to the lack of prioritizing Asian Americans for clinical trials. Asian Americans constituted just 2% of 102 596 US clinical trial participants, taken from 231 data snapshots of drug trials conducted between 2015 and 2019 and evaluated by the FDA ( 76 , 78 ). Given their low representation in clinical trials, the extent to which treatment guidelines are applicable to Asian Americans is unclear.…”