Racial and ethnic disparities in early cancer drug trials appear to be worsening, a new analysis found.
Researchers reported that overrepresentation of White patients in phase 1 cancer clinical trials increased between 2000 and 2018 while underrepresentation of Black and American Indian/Alaska Native patients, in particular, increased across the study period.
“These findings may represent widening inequalities in access to trial sites and worsening systemic biases,” wrote lead author Hayley Dunlop, MPH, of The Ohio State University College of Medicine, Columbus, and her colleagues.
While the authors acknowledged that the benefits of phase 1 trial participation are not typically as substantial as those for phase 3 trials, early trials set the stage for understanding the safety and effectiveness of new agents and may provide some quality of life and palliative care access benefits.
“Phase 1 clinical trials are the first step in determining a maximum tolerated dose and even an optimal cancer type for which a drug should be developed further,” Mikkael A. Sekeres, MD, MS, chief of the Division of Hematology at Sylvester Comprehensive Cancer Center, University of Miami, Miami-Dade County, Florida, told Medscape Medical News.
“When we don’t include an adequate number of patients from racial and ethnic minority populations in these trials, we may not be sure that the ultimate dose and cancer indication is right for these populations of patients,” said Sekeres, who was not involved in the study.
In the cross-sectional analysis, published earlier this month in JAMA Network Open, Dunlop and colleagues analyzed all completed US phase 1 drug trials for metastatic cancer between January 2000 and December 2018 that had published results. The 221 trials identified included 8309 adults with metastatic solid tumors.
The researchers then compared the racial and ethnic demographics in these trials with the demographics of the North American Association of Central Cancer Registries’ Cancer in North America (CiNA) database.
Among the trial participants, 86% were White compared with 84% of patients in the CiNA database. The overrepresentation of White patients in phase 1 drug trials increased over the study period — from a difference of 0.8 percentage points in 2000-2011 to a difference of 3.5 percentage points in 2012-2018.
Compared with the CiNA database, Black and American Indian/Alaska Native participants were underrepresented in phase 1 cancer trials across the study period and that underrepresentation increased over time.
Overall, Black patients represented 6.2% of participants in phase 1 trials compared with 11.8% of patients in the CiNA database. Over the study period, underrepresentation increased from a difference of 4 percentage points in 2000-2011 (7.5% vs 11.5%) to a difference of 6.9 percentage points in 2012-2018 (5.3% vs 12.2%).
American Indian/Alaska Native participants represented 0.3% of trial participants overall vs 0.4% of patients in the CiNA database, and their underrepresentation increased over time: 0.3% vs 0.4% from 2000-2011 and 0.3% vs 0.5% from 2012-2018.
Participation among Hispanic/Latinx and Asian/Pacific Islander patients also declined over time, but the trend was different. Compared with the CiNA database, Hispanic/Latinx were initially overrepresented in clinical trials (9% vs 6%) in 2000-2011, which shifted to slightly underrepresented (7.3% vs 7.5%) in 2012-2018. Similarly, Asian/Pacific Islander participants were initially overrepresented (3.7% vs 2.7%) in 2000-2011 but later underrepresented (3% vs 3.4%) in 2012-2018.
“We have a problem in cancer clinical research: our clinical trials do not [necessarily] reflect the populations of patients destined to receive the drugs being studied, should these drugs be approved by the [Food and Drug Administration],” Sekeres said.
The researchers recommended several ways to help improve representation in early cancer trials.
For instance, providing transportation, meal vouchers, and childcare support could help increase patient recruitment and engagement. The authors also suggested including hospital-at-home initiatives and community-academic partnerships that could help include participants who do not live close to academic centers where most trials are conducted.
Although these findings align with studies conducted at individual institutions, Sekeres explained that the study’s use of large datasets could have obscured progress made at some institutions.
But overall, Sekeres noted, it’s important for hematologist-oncologists and cancer centers to “work extra hard to bring these trials where people live and minimize obstacles to trial participation.”
The research was funded by the National Institutes of Health. One author reported consulting for Varian Medical Inc. Sekeres and Dunlop reported no disclosures.
JAMA Network Open. November 3, 2022. Abstract.
Tara Haelle is a health/science journalist based in Dallas, Texas. Follow her at @tarahaelle.
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