Worsening disparities observed in enrollment for early metastatic cancer-drug trials
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Racial and ethnic disparities in enrollment of patients to early-phase metastatic cancer-drug clinical trials worsened between 2000 and 2018, according to study results published in JAMA Network Open.
The findings indicate a need for increased efforts to diversify participation in these clinical trials to ensure access to novel cancer therapies and generalizability of results across racial and ethnic populations, researchers concluded.
Background and methods
“As a clinical cancer researcher who is dedicated to conducting clinical trials and promoting equity in health care access, I continue to see disparities in cancer clinical trial accruals,” C. Jillian Tsai, MD, PhD, radiation oncologist in the radiation medicine program at Princess Margaret Cancer Center in Toronto, told Healio. “To our knowledge, no published studies have specifically examined demographic disparities among participants in phase 1 cancer-drug development trials. This is particularly important, because if cancer drugs are not tested in a representative population, the safety and efficacy of these drugs may not be generalizable. Therefore, we decided to evaluate this topic.”
The cross-sectional study included data from 221 phase 1 clinical trials (74.7% industry-funded) of 8,309 patients (median age, 59 years; 50.5% men; 86.1% white) who received investigational treatment for metastatic tumors in the U.S. between 2000 and 2018.
Researchers compared the proportions of each racial/ethnic group in clinical trials with that of North American Association of Central Cancer Registries’ Cancer in North America database. They used two-sample tests for equality of proportions with continuity correction to examine differences between the clinical trials cohort vs. the database cohort.
Findings
Results showed inclusion of more white patients overall in the trials cohort compared with the database cohort (86.1% vs. 84.1%; P < .001).
Researchers also observed an increase in overrepresentation of white patients in the trials vs. database cohort from 2000 to 2011 (85.7% vs. 84.9%) to 2012 to 2018 (86.4% vs. 82.9%; P < .001).
Moreover, they observed corresponding worsening representation of American Indian/Alaska Native patients between 2000 and 2011 (0.3% vs. 0.4%) to between 2012 and 2018 (0.3% vs. 0.5%), as well as Asian/Pacific Islander patients (3.7% vs. 2.7% to 3% vs. 3.4%), Black patients (7.5% vs. 11.5% to 5.3% vs. 12.2%) and Hispanic/“Latinx” patients (9% vs. 6% to 7.3% vs. 7.5%).
Of note, researchers observed similar disparities when comparing industry-funded and academic center–sponsored trials.
Implications
“The findings are concerning,” Tsai said. “We did not expect to see worsening of disparities. There could be widening inequalities in access to trial sites and/or worsening systemic biases. We hope the manuscript can raise awareness that more efforts are needed to diversify phase 1 cancer-drug trials to improve equity in access to new treatments. There must be a more stringent requirement for trials to accrue patients from underrepresented populations.”
For more information:
C. Jillian Tsai, MD, PhD, can be reached at jillian.tsai@rmp.uhn.ca.
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