METHODOLOGICAL CONSIDERATIONS RELATED TO EQUITY, DIVERSITY, AND INCLUSION IN CLINICAL EPIDEMIOLOGY

Objectives: Oncology clinical trials are recommended to better reflect real-world cancer patient populations and to increase patient access to new treatments in trials. The influence of comorbidities on trial participation is unclear. This study examined the association of having comorbidities and patients' experiences with clinical trial discussion or actual participation.Study Design and Setting: We included 958 cancer survivors from Health Information National Trends Survey-Surveillance, Epidemiology, and End Results Program. Trial discussion was defined as whether their medical team discussed cancer clinical trials, and trial participation was defined as whether they participated. Comorbidities included diabetes, hypertension, heart condition, chronic lung dis-ease, and depression/anxiety disorder. Design-based logistic regression results were conducted.Results: Seventy-five percent of patients had one or more comorbidities, commonly having hypertension (56%) and diabetes (26%). Only 15% of participants reported trial discussion and 8% reported trial participation. Having one or more comorbidities was significantly associated with lower rates of trial discussion in univariate analysis (22.9% vs. 12.1%, odds ratio = 0.46, P = 0.001), and such association was pertained in adjusted logistic regression (20.5% vs. 12.8%, adjusted odds ratio = 0.54, P = 0.02).Conclusion: Findings suggest patients with comorbidities were underrepresented in cancer clinical trials, implying a potential lack of representativeness among trial participants. (c) 2023 Elsevier Inc. All rights reserved.