New study signals implications for diversity in clinical trials
Analysis finds Black survey respondents 8 percentage points more likely than their non-Hispanic White counterparts to be invited to participate in a clinical trial, yet 26 percentage points less likely to participate
Washington, DC (June 13, 2023) - Black survey respondents were 8 percentage points more likely than their non-Hispanic White counterparts to be invited to participate in a clinical trial; however, they were 26 percentage points less likely to participate - a statistically significant finding that was found repeatedly in a recent analysis commissioned by Pyxis Partners and conducted by graduate students at the McCourt School of Public Policy at Georgetown University. The goal of the analysis, “Evaluating the Impact of Health Insurance Coverage on Clinical Trial Participation among Racial/Ethnic Minorities and LGB Individuals”* was to elucidate the association between access to health insurance coverage and an individual’s decision to participate in clinical trials for racial/ethnic and Lesbian Gay Bisexual (LGB) populations respectively, but it also revealed this significant finding about Black Americans being invited at a higher rate, but with a notably lower participation rate.
While the cause of these findings could not be determined through the analysis, it may be that trial sponsors are conducting more outreach to communities underrepresented in biomedical research, such as Black American populations, to diversify clinical trials, but mistrust, hesitancy, or other barriers to participation impact enrollment.
“This examination of the intersection of health insurance, participation in clinical trials, and participation by underrepresented communities is at the heart of what Pyxis Partners does and is closely aligned to our vision, mission and values,” said Bobby Clark, Principal at Pyxis Partners. “While this is just one analysis, it demonstrates that more work and data are needed to address disparities in clinical trial participation among underrepresented communities.”
Based on the dataset identified, the analysis examined four questions:
consequences of the lack of diversity in clinical trial research and actions undertaken to address the problem through qualitative research alone
the role of insurance coverage on an individual’s decision to participate in clinical research
the effect of insurance coverage on racial/ethnic minorities’ willingness to participate
the role of insurance coverage on LGB minorities’ willingness to participate in clinical research
Additional findings from the study that can inform future research include:
Despite some meaningful programmatic changes, i.e. the Affordable Care Act and the Clinical Treatment Act, immovable costs associated with trials and general concerns about insufficient reimbursement serve as major deterrents to participation (Lin et al., 2008). Importantly, oncologist and physician recommendations play a notable role in generating knowledge of trials among patients, but available literature suggests that these recommendations are not informed by patients’ insurance status (Sullenger et al., 2022).
Analysis revealed notable progress in coverage levels for LGB+ minorities stemming from the passage of the Affordable Care Act and the legalization of same-sex marriage but a nonetheless persistent lack of equity. While the analyses show that the association between LGB and being invited to participate in clinical trials is statistically significant, the analysis was unable to report any statistically significant results due to the low number of LGB individuals in the sample, especially when subdividing them by insurance status and participation in clinical trials.
“This work demonstrates that we still have very little data about the relationship between participation in clinical trials and health insurance status for these populations, which made running this analysis difficult because of the small sample sizes,” said Clark. “This speaks to the importance of having more participation from communities historically underrepresented in biomedical research, especially racial and ethnic minorities and SGM people,” he said. “Having more participation from these communities is vitally important, not just for clinical research, but also quantitative analyses that can inform policy and programs.”
This is the second time Pyxis Partners has commissioned a study by graduate students at McCourt School of Public Policy at Georgetown University on issues regarding equity, access and affordability of healthcare.
Read the complete report here:
* The analysis used data from the publicly available National Cancer Institute’s Health Information National Trends Survey (HINTS) 5-Cycle 4. In general, HINTS surveys are designed to monitor access and use of health information for a nationally representative sample of American adults (HINTS 5 – Cycle 4 Methodology Report, 2020). Importantly, data for this cycle was collected near the start of the COVID-19 pandemic, specifically from February to June of 2020, from 3,850 U.S. civilian, non-institutionalized adults. Although the specific focus of this HINTS survey on cancer-related trends presents some priming concerns, the dataset provided important demographic information on trends in invitation and participation rates in clinical trial research which makes it highly useful for this research purpose. Importantly, this dataset was distributed to a randomly selected population and, while some questions ask about cancer, the respondents are not limited to cancer patients or survivors and the questions associated with the study variables of interest ask about clinical trials in general, not cancer-related clinical trials.
Although the students did not have a variable that captured willingness to participate in clinical trials specifically, they operationalize this construct using two different variables in the HINTS dataset, InvitedClinTrial (a measure that indicates whether an individual has ever been invited to participate in a clinical trial) and ParticipatedClinTrial (a measure that indicates whether an individual has ever participated in a clinical trial).
Pyxis Partners is a Washington, DC based public affairs and social impact firm that advances health equity, access and affordability with a unique expertise in authentic work around equity, diversity and inclusion in the healthcare and clinical trial universe. The firm is defined by developing creative solutions that create pathways to progress which are anchored in a commitment to improving the lives of others and building up communities. Pyxis Partners is fueled by a collective passion for lifting the voice of those who have been underrepresented. The firm is a Certified LGBT Business Enterprise with the National Gay and Lesbian Chamber of Commerce (NGLCC) and Certified by the Department of Small and Local Business Development (DSLBD) as a District of Columbia Certified Business Enterprise.