Integrating clinical trial data with electronic health records to improve diversity in research: findings from an urban hospital system.

backgroundUnderrepresentation of racial and ethnic minorities, women, and certain age groups in clinical trials continues to threaten the validity of novel therapeutic interventions and exacerbate longstanding inequities in health outcomes. Despite attention and mandates across institutions and federal agencies to address these disparities, effective and actionable strategies have remained a subject of debate in the existing literature. This study provides preliminary findings from the Advancing Research Through Inclusivity, Sustainability, and Equity (ARISE) Program, a quality improvement initiative to improve representation of racial and ethnic minorities and other underrepresented populations (e.g., women, certain age groups) in clinical trials conducted in an urban hospital system. The primary objective of this study was to examine the racial and ethnic distribution of research participants enrolled in drug and device clinical trials from 2017 to 2024. The secondary objective was to integrate electronic health records and local census data to create benchmarks for comparative purposes.

methodsThis study employed a successive-independent samples design to characterize the demographic distribution of 1767 adult research participants enrolled in a drug or device clinical trial from 2017 to 2024. Demographic data were integrated from electronic health records and summarized overall and by year. The z-test for independent proportions was used to compare the research participant demographics to the overall patient population (N = 2,062,865) and local census (N = 608,210). Effect size estimates were calculated using Cohen's h to determine practically significant differences between research participants, the overall patient population, and local census.

resultsResearch participants were more likely than the patient population to represent older age groups (55-74 years) and White race (83.1% vs 73.1%) but were comparable in terms of ethnicity and biological sex. When compared to local census data, research participants were more likely to represent older age groups, while increases in White participants and decreases in Black participants were observed. There were increases in the proportions of Black and female participants from 2017 to 2024, while White participation decreased. The proportion of Hispanic research participation fluctuated from 2017 to 2024 but remained below census and patient population levels (4.7% and 5.3%, respectively).

conclusionsThe findings from this study will directly inform future strategies of the ARISE Program for setting enrollment goals and creating recruitment metrics that facilitate increased representation of racial and ethnic minorities and other health disparity populations in clinical trials. Future studies should integrate primary and secondary data to take into consideration the eligibility criteria from clinical trials as an additional benchmark comparison when making inferences about diversity and representation.