Socioeconomically disadvantaged patients underrepresented in structural heart trials
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Among hospitals performing transcatheter mitral and tricuspid valve therapies, those involved in clinical trials had fewer socioeconomically disadvantaged patients than those not involved, researchers reported.
There were no significant differences by race and ethnicity between patients from trial hospitals and those from non-trial hospitals.
“If hospitals that participate in clinical trials take care of relatively few minoritized or socioeconomically disadvantaged patients, this would represent a systemic barrier to trial access due to site selection issues,” Ashwin Nathan, MD, MS, assistant professor of medicine at the Hospital of the University of Pennsylvania, said during a presentation at TVT: The Structural Heart Summit. “We asked, what are the racial, ethnic and socioeconomic characteristics of patients treated at sites that do participate in clinical trials for novel transcatheter valve therapies compared to candidate sites that do not participate in these trials?”
Nathan and colleagues identified 1,050 U.S. hospitals with cardiac surgery programs, of which 121 participated in clinical trials for transcatheter mitral and tricuspid valve therapies according to clinicaltrials.gov.
Compared with non-trial hospitals, trial hospitals were larger (79.3% with at least 400 beds vs. 30.4%; P < .0001), were more likely to be teaching hospitals (61.2% vs. 16.6%; P < .0001) and were more likely to be located in metropolitan areas (99.2% vs. 94.8%; P = .03), Nathan said.
After adjustment for hospital and patient clinical characteristics, patients from trial hospitals had higher median household income compared with patients from non-trial hospitals (difference, $5,261; 95% CI, 2,986-7,537; P < .0001), he said.
The difference between the proportion of Black and Hispanic patients treated at trial vs. non-trial hospitals was less than 1% (difference in Black patients, 0.09%; 95% CI, –0.01 to 0.18; P = .06; difference in Hispanic patients, 0.02%; 95% CI, –0.03 to 0.09; P = .36), according to the researchers.
“These data would suggest that broader inclusion of potential clinical trial sites may improve access to clinical trials among socioeconomically disadvantaged patients, but efforts to improve access to trials to Black and Hispanic patients should also focus on enhancing enrollment efforts for these patients within existing sites,” Nathan said during the presentation.
The site selection process favors the same large sites because of the need to complete recruitment goals and stick to project timelines, so ways to include more socioeconomically disadvantaged patients could be to reduce site-level administrative and financial burdens and to incentivize sites for including more socioeconomically disadvantaged patients, Ashwin said.
To improve racial and ethnic diversity in trials, “consider racially and ethnically stratified targets prior to recruitment, seek community-focused approaches to guide development of strategies for recruitment and improve inclusivity among investigators,” he said.
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Nathan A, et al. Late-Breaking Clinical Trials. Presented at: TVT: The Structural Heart Summit; June 8-10, 2022; Chicago (hybrid meeting).
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