SAN FRANCISCO, CA USA (UroToday.com) - The objective of this study, by Dr. Kristian Stensland and colleagues, was to determine the scope of issues that lead to early termination of clinical trials in GU oncology.
They conducted this study by querying clinicaltrials.gov to identify all phase II-III interventional adult cancer clinical trials that terminated early between 9/11/05 and 11/11/11. They identified 7 776 trials, including 491 prostate (PCa), 142 kidney, 75 bladder, and 34 testis cancer trials. The risk of premature termination due to any cause for all cancers was 25% (95% CI 19-31%), and the risk due to poor accrual was 10% (95% CI 9-12%). Poor accrual was the most common reason for premature termination. Risk was not significantly different for kidney, bladder or testis cancers compared to other cancer types with the exception of PCa (HR 1.35 [1.03-1.78]). Industry-funded trials were more likely to terminate prematurely (HR 2.26 [1.83-2.80]). Trials with sites outside of the USA (HR 0.63 [0.54-0.74]) or both within and outside of the USA (HR 0.68 [0.54-0.74]) were less likely to terminate prematurely as were trials with multiple sites (HR 0.56 [0.48-0.64]).
In summary, about 1-in-4 trials terminated prematurely (1-in-10 due to poor accrual). GU cancer trials were at similar risk of termination compared to other cancer clinical trials with the exception of PCa.
Highlights of a presentation by Kristian Stensland at the 2014 Genitourinary Cancers Symposium - January 30 - February 1, 2014 - San Francisco Marriott Marquis - San Francisco, California USA
Mt. Sinai School of Medicine, New York, NY USA
Click HERE to listen to an exclusive interview with one of the authors of this study
Click HERE to view the poster from this session
Click HERE to view the slides from this session