Characteristics of Clinical Trial Sites for Novel Transcatheter Mitral and Tricuspid Valvular Therapies

Abstract

ImportanceRacial and ethnic minority and socioeconomically disadvantaged patients have been underrepresented in randomized clinical trials. Efforts have focused on enhancing inclusion of minority groups at sites participating at clinical trials; however, there may be differences in the patient populations of the sites that participate in clinical trials.ObjectiveTo identify any differences in the racial, ethnic, and socioeconomic composition of patient populations among candidate sites in the US that did vs did not participate in trials for novel transcatheter therapies.Design, Setting, and ParticipantsThis cross-sectional analysis used Medicare Provider Claims from 2019 for patients admitted to hospitals in the US. All clinical trials for transcatheter mitral and tricuspid valve therapies and the hospitals participating in each of the trials were identified using ClinicalTrials.gov. Hospitals with active cardiac surgical programs that did not participate in the trials were also identified. Data analysis was performed between July 2021 and July 2022.ExposuresMultivariable linear regression models were used to identify differences in racial, ethnic, and socioeconomic characteristics among patients undergoing cardiac surgery or transcatheter aortic valve replacement at trial vs nontrial hospitals.Main Outcome and MeasuresThe main outcome of the study was participation in a clinical trial for novel transcatheter mitral or tricuspid valve therapies.ResultsA total of 1050 hospitals with cardiac surgery programs were identified, of which 121 (11.5%) participated in trials for transcatheter mitral or tricuspid therapies. Patients treated in trial hospitals had a higher median zip code–based household income (difference of $5261; 95% CI, $2986-$7537), a lower Distressed Communities Index score (difference of 5.37; 95% CI, 2.59-8.15), and no significant difference in the proportion of patients dual eligible for Medicaid (difference of 0.86; 95% CI, −2.38 to 0.66). After adjusting for each of the socioeconomic indicators separately, there was less than 1% difference in the proportion of Black and Hispanic patients cared for at hospitals participating vs not participating in clinical trials.Conclusions and RelevanceIn this cohort study among candidate hospitals for clinical trials for transcatheter mitral or tricuspid valve therapies, trial hospitals took care of a more socioeconomically advantaged population than nontrial hospitals, with a similar proportion of Black and Hispanic patients. These data suggest that site selection efforts may improve enrollment of socioeconomically disadvantaged patients but may not improve the enrollment of Black and Hispanic patients.

Enrollment of Older Patients, Women, and Racial and Ethnic Minority Individuals in Valvular Heart Disease Clinical Trials

“…However, prior research from our group has shown that diverse site selection alone may not sufficiently improve racial and ethnic diversity among clinical trial populations, given the similar racial and ethnic demographics of patients served by US clinical trial sites for novel transcatheter mitral and tricuspid valve therapies vs sites not conducting clinical trials . Thus, US hospitals involved in clinical trials must actively engage their Black and Hispanic communities to improve enrollment in clinical trials . Future efforts may benefit from focusing on social determinants of health, such as improving access to transportation and childcare services for Black and Hispanic patients, who may be limited in participating in trials by an inability to leave work and/or find care for children and other dependents during multiple study visits …”

“…There are currently limited data on the enrollment of socioeconomically disadvantaged populations in clinical trials. Prior work from our group has shown that sites that participate in clinical trials for VHD care for patients who are wealthier and have higher levels of socioeconomic status than candidate hospitals that do not . Increased access for these patients may be spurred by a priori decision-making at site selection for clinical trials.…”

Equity in Clinical Trial Participation Requires Equity in Identification and Treatment of Valvular Heart Disease

“…Nathan et al sought to shine light on the degree to which the characteristics of patients undergoing transcatheter mitral and tricuspid valve surgery differ between hospitals that do and do not participate in clinical trials of transcatheter mitral and tricuspid valve procedures. The researchers found that the racial and ethnic makeup of patients undergoing cardiac surgery in hospitals that participated in clinical trials vs those that did not was similar.…”

“…Unfortunately, disparities in the socioeconomic status of persons participating in large cardiovascular outcomes trials are harder to quantify, as socioeconomic indicators are not routinely collected. In contrast to what was seen for race and ethnicity, Nathan et al found that hospitals that did not participate in clinical trials did care for more socioeconomically disadvantaged patients. This highlights the need to improve support for clinical trials in health systems that care for a greater number of socioeconomically disadvantaged persons.…”

“…The findings in Nathan et al highlight an even more important barrier to diversity in clinical trial participation in patients with valvular disease: disparities in identification and referral for valve intervention in the first place. In the present analysis, Black and Hispanic patients represented fewer than 5% of patients undergoing cardiac surgery or transcatheter aortic valve replacement at both trial and nontrial hospitals, a dramatically lower proportion than would be expected based on the demographic characteristics of persons in the US.…”