Reporting and representation of participant race and ethnicity in phase III clinical trials for solid tumors
Creators: name: Wang, Tianyi
name: Villanueva, Dinorah J
name: Banerjee, Ambily
name: Gifkins, Dina
Publisher: name: Taylor & Francis
Year: 2025
Subjects: subject: Medicine
subject: Pharmacology
subject: Biotechnology
subject: Sociology
subject: FOS: Sociology
subject: Cancer
subject: Science Policy

description: Including racial and ethnic minorities in clinical trials is essential for advancing health equity. Despite progress, trials often do not mirror patient population demographics. The National Library of Medicine’s Clinical Trials database was queried for phase III trials of lung, colorectal, breast, and prostate cancers. A reference population was identified from the Surveillance, Epidemiology, and End Result (SEER) database, covering 48% of the US population. Among 181 trials, race and ethnicity data were included in 86.7% and 60.2% of trials, respectively, with improving reporting over time. Participants were predominantly White (76.3%), followed by Asian/Pacific Islander (14.1%), Black/African American (4.5%), and American Indian/Alaska Native (0.6%). Hispanic/Latino constituted 6.4% of participants. The proportion of non-White groups increased from 19.4% in trials started before 2011 to 26.2% after 2015. Compared with SEER data, the percentages were lower for Asian/Pacific Islander across all cancers, Black/African American in breast and prostate cancers, American Indian or Alaska Native in colorectal, breast, and prostate cancers in US solely trials. Reporting and enrollment of racial and ethnic minorities in trials remain inadequate but improving. To enhance diversity, real-world data are warranted to identify recruitment goals by better assessing the geographic distribution within the patient population. Including people from different racial and ethnic backgrounds in clinical trials is crucial for ensuring fair health outcomes. Currently, many clinical trials do not accurately reflect the demographics of the patient population. This study looked at clinical trials for lung, colorectal, breast, and prostate cancers using the National Library of Medicine’s Clinical Trials database. Researchers analyzed data from 181 clinical trials. The findings revealed that only 87% and 60% of clinical trials reported on race and ethnicity data, separately. Most trial participants were White (76%), with smaller numbers of Asian/Pacific Islander (14%), Black/African American (5%), American Indian/Alaska Native (1%), and Hispanic/Latino (6%). The representation of non-White participants has been slowly improving over time, yet these groups remain underrepresented. Overall, the study highlights the ongoing need for better diversity in clinical trials. To achieve more equitable representation, new strategies are necessary, including using real-world data to guide recruitment efforts for a more accurate reflection of the patient population. Pioneering Analysis: This is the first analysis to systematically evaluate racial and ethnic representation in phase III trials for lung, colorectal, breast, and prostate cancers.Underreporting and Underrepresentation of Racial and Ethnic Minorities: Reporting and enrollment of racial and ethnic minorities in trials remains inadequate but appears to be slowly improving.Call for Future Action: These findings highlight the need for innovative strategies and the use of real-world data to improve diversity and achieve equity in clinical trial enrollment. Pioneering Analysis: This is the first analysis to systematically evaluate racial and ethnic representation in phase III trials for lung, colorectal, breast, and prostate cancers. Underreporting and Underrepresentation of Racial and Ethnic Minorities: Reporting and enrollment of racial and ethnic minorities in trials remains inadequate but appears to be slowly improving. Call for Future Action: These findings highlight the need for innovative strategies and the use of real-world data to improve diversity and achieve equity in clinical trial enrollment.