Mp68-10 Understanding the Termination of Urological Cancer Clinical Trials: Insights, and Challenges

You have accessJournal of UrologyProstate Cancer: Epidemiology & Natural History II (MP68)1 May 2024MP68-10 UNDERSTANDING THE TERMINATION OF UROLOGICAL CANCER CLINICAL TRIALS: INSIGHTS, AND CHALLENGES Abdulrahman Alhajahjeh, Layla El-amayreh, David I. Lee, Bashir Al Hussein Al Awamlh, and Mohammed Shahait Abdulrahman AlhajahjehAbdulrahman Alhajahjeh , Layla El-amayrehLayla El-amayreh , David I. LeeDavid I. Lee , Bashir Al Hussein Al AwamlhBashir Al Hussein Al Awamlh , and Mohammed ShahaitMohammed Shahait View All Author Informationhttps://doi.org/10.1097/01.JU.0001008744.60568.e8.10AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Clinical trials are a valuable source of evidence for managing urologic malignancies. Early termination of clinical trials is associated with a waste of resources and may substantially affect patient care. We sought to study the termination rate of urological cancer clinical trials and identify factors associated with trial termination. METHODS: A cross-sectional search of ClinicalTrials.gov identified completed and terminated kidney, prostate, and bladder cancer clinical trials started and completed between 2000 and 2020. Trials were assessed for reasons for termination. Multivariable analyses were conducted to look for the significant factor associated with the termination. RESULTS: Between 2000 and 2020, a total of 9,145 oncology clinical trials were conducted, out of which 11.30% (n=1033) were urological cancer clinical trials. Prostate cancer clinical trials constituted the majority with 62.24% (n=643), followed by renal cell carcinoma clinical trials with 24.20% (n=250), and bladder cancer clinical trials with 13.41% (n=140). Of the urological cancer clinical trials, 25.38% (n=265) were terminated, with low patient accrual being the most common reason for termination 52.9% (n=127). Univariable analysis revealed significant associations between trial termination and university funding, single-center studies, number of patients <50, surgical intervention trials, phase 2 trials, and unmasked trials. Multivariable analysis showed that only the university funding source OR 2.20 (95% [CI: 1.45-3.32]), single-center studies OR 2.11 (95% [CI: 1.59-2.81]), and sample size <50 were significant predictors of clinical trial termination OR 5.26 (95% [CI: 3.85-7.69]); all p-value <0.001. CONCLUSIONS: The termination rate of urological cancer clinical trials was 25%, with low accrual being the most frequently reported reason. Trials funded by a university, single-center trials, and small trials (sample size <50) were associated with early termination. A better understanding of these factors might help researchers, funding agencies, and other stakeholders to prioritize resource allocations for multicenter trials that aim to recruit sufficient number of patients. Download PPT Source of Funding: No funding © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e1111 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Abdulrahman Alhajahjeh More articles by this author Layla El-amayreh More articles by this author David I. Lee More articles by this author Bashir Al Hussein Al Awamlh More articles by this author Mohammed Shahait More articles by this author Expand All Advertisement PDF downloadLoading ...