Socioeconomically Disadvantaged Patients Underrepresented in Structural Cardiac Trials
Nathan A, et al. Last minute clinical trials. Featured at: TVT: Top of the Structural Core; June 8-10, 2022; Chicago (hybrid meeting).
Disclosures: Nathan reports receiving institutional research funding from Abiomed.
Among hospitals performing transcatheter mitral and tricuspid therapy, those involved in the clinical trials had fewer socioeconomically disadvantaged patients than those not involved, the researchers reported.
There were no significant differences by race and ethnicity between patients in trial hospitals and those in non-trial hospitals.
“If hospitals participating in clinical trials serve relatively few minority 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 University of Pennsylvania Hospital, 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 participate in clinical trials for new transcatheter valve therapies versus candidate sites that do not participate in these trials?”
Nathan and his colleagues identified 1,050 US hospitals with cardiac surgery programs, 121 of which participated in clinical trials for mitral and tricuspid transcatheter therapies according to clinictrials.gov.
Compared to hospitals without a trial, trial hospitals were larger (79.3% with at least 400 beds versus 30.4%; P P P = .03), says Nathan.
After adjusting for hospital and patient clinical characteristics, patients in the trial hospitals had a higher median household income than patients in the non-trial hospitals (difference, $5,261 95% CI, 2986-7537; P
The difference between the proportion of black and Hispanic patients treated in the trial compared to hospitals that did not participate in the trial was less than 1% (difference in black patients, 0.09%; 95% CI , -0.01 to 0.18; P = 0.06; 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 for patients Blacks and Hispanics should also focus on improving enrollment efforts for these patients at existing sites,” Nathan said during the presentation.
The site selection process favors the same large sites due to the need to meet recruitment goals and meet project deadlines. Therefore, ways to include more socio-economically disadvantaged patients could be to reduce administrative and financial burdens at the site level and incentivize sites to include more socio-economically disadvantaged patients. 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 the development of recruitment strategies, and improve inclusiveness among interviewers” , did he declare.