Clinical Trial Outcomes in Urology: Assessing Early Discontinuation, Results Reporting and Publication in ClinicalTrials.Gov Registrations 2007-2019.

purposeClinical trials require significant resources, but benefits are only realized after trial completion and dissemination of results. We comprehensively assessed early discontinuation, registry results reporting, and publication by trial sponsor and subspecialty in urology trials. MATERIALS AND

methodsWe assessed trial registrations from 2007 to 2019 on ClinicalTrials.gov and publication data from PubMed®/MEDLINE®. Associations between sponsor or subspecialty with early discontinuation were assessed using Cox proportional hazards and results reporting or publication with logistic regression at 3 years after completion.

resultsOf 8,636 trials 3,541 (41.0%) were completed and 999 (11.6%) were discontinued. Of completed trials 26.9% reported results and 21.6% were published. Sponsors included academic institutions (53.1%), industry (37.1%) and the U.S. government (9.8%). Academic-sponsored (adjusted HR 0.81, 95% CI 0.69-0.96, p=0.012) and government-sponsored trials (adjusted HR 0.62, 95% CI 0.49-0.78, p <0.001) were less likely than industry to discontinue early. Government-sponsored trials were more likely to report (adjusted OR 1.72, 95% CI 1.17-2.54, p=0.006) and publish (adjusted OR 1.89, 95% CI 1.23-2.89, p=0.004). Academic-sponsored trials were less likely to report (adjusted OR 0.65, CI:0.48-0.88, p=0.006) but more likely to publish (adjusted OR 1.72, 95% CI 1.25-2.37, p <0.001). These outcomes were similar across subspecialties. However, endourology was more likely to discontinue early (adjusted HR 2.00, 95% CI 1.53-2.95, p <0.001), general urology was more likely to report results (adjusted OR 1.54, 95% CI 1.13-2.11, p=0.006) and andrology was less likely to publish (adjusted OR 0.53, 95% CI 0.35-0.81, p=0.003).

conclusionsSponsor type is significantly associated with trial completion and dissemination. Government-sponsored trials had the best performance, while industry and academic-sponsored trials lagged in completion and results reporting, respectively. Subspecialty played a lesser role. Lack of dissemination remains a problem for urology trials.