Clinical Trial Diversity, Equity & Inclusion: Roadmap of the Cardiothoracic Surgical Trials Network

BACKGROUND There is a recognized lack of diversity among patients enrolled in cardiovascular interventional and surgical trials. Diverse patient representation in clinical trials is necessary to enhance generalizability of findings, which may lead to better outcomes across broader populations. The Cardiothoracic Surgical Trials Network (CTSN) recently developed a plan-of-action to increase diversity among participating investigators and trial participants -- the focus of this paper. METHODS Review of literature and enrollment data from CTSN trials. RESULTS More than a dozen major clinical trials were completed by CTSN (2008-2022), enrolling over 4,000 patients, of whom 30% were women 11% non-White and 5.6% were Hispanic. The Network also completed trials of hospitalized COVID-19 patients, wherein enrollment was more diverse, with 42% women and 58% either Asian, Black, Hispanic or from another underrepresented racial group. The discrepancy in diversity of enrollment between cardiac surgery trials and COVID trials highlights the need for a more comprehensive understanding of: 1) the prevalence of underlying disease requiring cardiac interventions across broad populations, 2) differences in access to care and referral for cardiac surgery, and 3) barriers to enrollment in cardiac surgery trials. CONCLUSIONS Committed to diversity, CTSN’s multi-faceted action plan includes developing site-specific enrollment targets, collecting social determinants of health data, understanding reasons for non-participation, recruiting sites that serve diverse populations, emphasizing greater diversity among clinical trial teams, and implicit bias training. The CTSN will prospectively assess how these interventions influence enrollment as we work to ensure trial participants are more representative of the communities we serve.