Using Bayesian hierarchical modeling for performance evaluation of clinical trial accrual for a cancer center

• الحاوية / القاعدة: Contemporary Clinical Trials Communications
• المؤلفون الرئيسيون: Xiaosong Shi, Dinesh Pal Mudaranthakam, Jo A. Wick, David Streeter, Jeffrey A. Thompson, Natalie R. Streeter, Tara L. Lin, Joseph Hines, II, Matthew S. Mayo, Byron J. Gajewski
• التنسيق: مقال
• اللغة: الإنجليزية
• منشور في: Elsevier 2024-04-01
• الموضوعات: Patient recruitment; Performance assessment; Bayesian methods
• الوصول للمادة أونلاين: http://www.sciencedirect.com/science/article/pii/S2451865424000280

Introduction: Slow patient accrual in cancer clinical trials is always a concern. In 2021, the University of Kansas Comprehensive Cancer Center (KUCC), an NCI-designated comprehensive cancer center, implemented the Curated Cancer Clinical Outcomes Database (C3OD) to perform trial feasibility analyses using real-time electronic medical record data. In this study, we proposed a Bayesian hierarchical model to evaluate annual cancer clinical trial accrual performance. Methods: The Bayesian hierarchical model uses Poisson models to describe the accrual performance of individual cancer clinical trials and a hierarchical component to describe the variation in performance across studies. Additionally, this model evaluates the impacts of the C3OD and the COVID-19 pandemic using posterior probabilities across evaluation years. The performance metric is the ratio of the observed accrual rate to the target accrual rate. Results: Posterior medians of the annual accrual performance at the KUCC from 2018 to 2023 are 0.233, 0.246, 0.197, 0.150, 0.254, and 0.340. The COVID-19 pandemic partly explains the drop in performance in 2020 and 2021. The posterior probability that annual accrual performance is better with C3OD in 2023 than pre-pandemic (2019) is 0.935. Conclusions: This study comprehensively evaluates the annual performance of clinical trial accrual at the KUCC, revealing a negative impact of COVID-19 and an ongoing positive impact of C3OD implementation. Two sensitivity analyses further validate the robustness of our model. Evaluating annual accrual performance across clinical trials is essential for a cancer center. The performance evaluation tools described in this paper are highly recommended for monitoring clinical trial accrual.