A new study finds that the racial composition of clinical trials involving radiation therapy does not match that of the U.S. population. Examining trials from the past 23 years, researchers found that roughly 12% of trial participants were Black, which is less than the 13% of African Americans in the U.S. census and does not account for disproportionately higher rates of cancer incidence and death among African Americans. Asian American patients were also underrepresented in the trials relative to their population size. Findings will be presented today at the American Society for Radiation Oncology (ASTRO) Annual Meeting.
“Clinical trials should reflect the diversity that exists in a population, yet we know challenges exist in both recruitment and retention of trial participants from racial minority groups. Understanding and minimizing disparities in clinical trials is critical to ensure health equity and the generalizability of research findings,” said Emily H. Bero, a medical student at the Medical College of Wisconsin in Milwaukee and lead author of the study. "Our study looks specifically at representation in radiation therapy trials."
Challenges with racial diversity in clinical trials are well established, for trials generally as well as those specific to cancer. A 2018 ProPublica analysis, for example, found that fewer than 5% of patients in trials for recently FDA-approved cancer drugs were Black, yet African Americans account for 13% of the U.S. population. Enrollment data from cancer trials indicates that inclusion of patients from racial/ethnic groups in those studies has gotten worse over time.
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For the current analysis, researchers examined clinical trials involving radiation therapy that were posted from 1996 to 2019 on clinicaltrials.gov, a global database of trials that is maintained by the U.S. National Library of Medicine. A total of 122 trials (of 1,242 reviewed) met inclusion criteria, and researchers compared the percentages of different race groups in those trials with U.S. census estimates from 2018.
The racial composition of radiation therapy trials was statistically different from the census estimates. Combined, the trials included 84% white patients, 12% Black patients, 3% Asian American patients and less than 1% patients from other races (Native Hawaiian, Pacific Islander, American Indian, Alaskan native) or more than one race group. By comparison, the census figures were 72% white (12 percentage points lower than the trials), 13% Black (1 point higher than the trials), 6% Asian (3 points higher) and 9% from other races (8 points higher). Because race and ethnicity (i.e., Hispanic or Latino origin) are separate categories on the U.S. census, inclusion of Hispanic patients in clinical trials was not examined in the study.