Black patients less represented in pharmaceutical-led vs. NCI-sponsored cancer trials
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Black patients with cancer have been significantly underrepresented in pharmaceutical company-sponsored clinical trials, according to study results presented at American Association for Cancer Research Virtual Annual Meeting II.
“My colleagues and I previously examined the rate of Black participation in trials that led to new FDA drug approvals, and we found that most trials leading to new drug approvals are sponsored by pharmaceutical companies. It is known that NCI-sponsored network groups are determined to provide access to trials for vulnerable populations,” Joseph Unger, PhD, MS, Southwest Oncology Group (SWOG) health services researcher and associate professor in the division of public health sciences at Fred Hutchinson Cancer Research Center, told Healio. “This is what led me to investigate whether NCI-sponsored trials had better representation of Black patients compared with pharmaceutical-sponsored studies after controlling for cancer type and period of enrollment.”
Investigators compared the representation of Black patients in 74 pharmaceutical company-sponsored clinical trials that supported new FDA-approved agents with that of 153 National Clinical Trials Network (NCTN) trials included in the SWOG Cancer Research Network. They additionally used data from the SEER database and U.S. Census Bureau to estimate the expected rate of participation by Black patients for the cancers studied, comparing the proportion of Black patients by enrollment year overall and for specific cancer types.
Results showed the overall proportion of Black patients was 2.9% for pharmaceutical company-sponsored trials, 8.3% for SWOG trials and 12.1% for the U.S. cancer population.
The proportion of Black patients was significantly lower for pharmaceutical company-sponsored trials across all cancer types, except for melanoma, compared with SWOG trials and the U.S. cancer population, researchers noted.
“It was surprising to see how different the rates of Black participation in trials were — NCI-sponsored trials enrolled three-times more Black patients than pharmaceutical-sponsored trials. This was a dramatic finding,” Unger said. “We are all familiar with the statistic that suggests only about 5% of adult patients with cancer participate in clinical trials. My colleagues and I are now working to address a more specific question: How often do patients who are offered a clinical trial agree to participate? We are focusing on whether there are differences in rates of agreement by race and ethnicity, given the notable disparities in access to trials for vulnerable populations.”
Perspective
Back to TopJong Park, PhD, and Clement Gwede, PhD, MPH, RN, FAAN
Most cancers disproportionately affect Blacks compared with whites. Although differences in access to medical care, socioeconomic status and molecular genetic profiles are contributing factors to disparities in cancer risk and prognosis, underrepresentation of minority patients in clinical trials may exacerbate these disparities.
Poor representation of Blacks in clinical trials, especially pharmaceutical company-sponsored trials, may explain why new drugs are often less effective for Black patients. However, increased Black representation in NCTN trials is encouraging.
The reasons for underrepresentation are not well-documented, but it is plausible, among other reasons, that pharmaceutical company-sponsored trials are not widely conducted in community oncology sites or geographic locations with high representation of Black patients. As such, proactive and targeted recruitment of community oncology clinical trial sites and investigators is important to increasing participation of Black patients. For NCTN trials, the NCI Community Oncology Resource Program infrastructure may be largely responsible for improved diversity and representation of racial and ethnic minorities, as this resource extends access of clinical trials to community oncology sites, where the majority of care is delivered. It has been widely documented that racial and ethnic minorities will participate in clinical trials if meaningful access is provided — for example, if they are offered a trial and meet eligibility criteria. Hence, efforts to address this underrepresentation in pharmaceutical company-sponsored trials must include expanded access and equitable inclusion criteria, among other improvements. Unger and colleagues stated that FDA is examining strategies to increase representation of Black patients in FDA registration trials. This policy may help to improve representation in clinical trials, both overall and for pharmaceutical-sponsored trials specifically.
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Unger JM, et al. Abstract 4344/8. Presented at: American Association for Cancer Research Virtual Annual Meeting II; June 22-24, 2020.
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