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Clinical Trial Outcomes in Urology: Assessing Early Discontinuation, Results Reporting, and Publication in ClinicalTrials.Gov Registrations 2007-2019. The Journal of urology Magnani, C. J., Steinberg, J. R., Harmange, C. I., Zhang, X. n., Driscoll, C. n., Bell, A. n., Larson, J. n., You, J. G., Weeks, B. T., Turner, B. E., Brooks, J. D. 2020: 101097JU0000000000001432

Abstract

Clinical 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.We assessed trial registrations from 2007-2019 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 three years after completion.Of 8,636 trials, 3,541 (41.0%) were completed while 999 (11.6%) were discontinued. 26.9% of completed trials reported results, and 21.6% were published. Sponsors included Academic institutions (53.1%), Industry (37.1%), or US Government (9.8%). Academic-sponsored (adjusted hazard ratio (aHR):0.81, 95% Confidence Interval (CI):0.69-0.96, p=0.012) and Government-sponsored trials (aHR: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 odds ratio (aOR):1.72, 95%CI:1.17-2.54, p=0.006) and publish (aOR:1.89, 95%CI:1.23-2.89, p=0.004). Academic-sponsored were less likely to report (aOR:0.65, CI:0.48-0.88, p=0.006) but more likely to publish (aOR: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 (aHR:2.00, 95%CI:1.53-2.95, p <0.001), general urology more likely to report results (aOR:1.54, 95%CI:1.13-2.11, p=0.006), and andrology less likely to publish (aOR:0.53, 95%CI:0.35-0.81, p=0.003).Sponsor type is significantly associated with trial completion and dissemination; Government-sponsored trials had the best performance while Industry and Academic-sponsored lagged in trial completion and results reporting, respectively. Subspecialty played a lesser role. Lack of dissemination remains a problem for urology trials.

View details for DOI 10.1097/JU.0000000000001432

View details for PubMedID 33079618