School of Medicine, Stanford University, Stanford, California.
Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois.
J Urol. 2021 Apr;205(4):1159-1168. doi: 10.1097/JU.0000000000001432. Epub 2020 Oct 20.
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 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.
Of 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).
Sponsor 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.
临床试验需要大量资源，但只有在试验完成并公布结果后才能获得益处。我们全面评估了泌尿科试验中早期终止、注册结果报告和试验赞助商及亚专业领域的发表情况。
我们评估了 2007 年至 2019 年在 ClinicalTrials.gov 上的试验注册情况以及 PubMed®/MEDLINE®上的发表数据。使用 Cox 比例风险和 3 年后完成的结果报告或发表的逻辑回归来评估赞助商或亚专业领域与早期终止之间的关联。
在 8636 项试验中，有 3541 项（41.0%）完成，999 项（11.6%）提前终止。在完成的试验中，有 26.9%报告了结果，21.6%发表了。赞助商包括学术机构（53.1%）、行业（37.1%）和美国政府（9.8%）。学术机构赞助的试验（调整后的 HR 0.81，95%CI 0.69-0.96，p=0.012）和政府赞助的试验（调整后的 HR 0.62，95%CI 0.49-0.78，p<0.001）比行业赞助的试验更不容易提前终止。政府赞助的试验更有可能报告（调整后的 OR 1.72，95%CI 1.17-2.54，p=0.006）和发表（调整后的 OR 1.89，95%CI 1.23-2.89，p=0.004）。学术机构赞助的试验更不容易报告（调整后的 OR 0.65，CI：0.48-0.88，p=0.006），但更有可能发表（调整后的 OR 1.72，95%CI 1.25-2.37，p<0.001）。这些结果在各个亚专业领域都相似。然而，腔内泌尿外科更有可能提前终止（调整后的 HR 2.00，95%CI 1.53-2.95，p<0.001），普通泌尿外科更有可能报告结果（调整后的 OR 1.54，95%CI 1.13-2.11，p=0.006），而男科更不可能发表（调整后的 OR 0.53，95%CI 0.35-0.81，p=0.003）。
赞助商类型与试验完成和传播有显著关联。政府赞助的试验表现最好，而行业和学术机构赞助的试验分别在完成和结果报告方面表现不佳。亚专业领域的作用较小。缺乏传播仍然是泌尿科试验的一个问题。
