Clinical Trial Outcomes in Urology: Assessing Early Discontinuation, Results Reporting and Publication in ClinicalTrials.Gov Registrations 2007-2019.
Clinical Trial Outcomes in Urology: Assessing Early Discontinuation, Results Reporting and Publication in ClinicalTrials.Gov Registrations 2007-2019.
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DOI：
10.1097/ju.0000000000001432
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发表时间：
2021-04
期刊：
影响因子：
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通讯作者：
Brooks JD
中科院分区：
文献类型：
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作者：
Magnani CJ;Steinberg JR;Harmange CI;Zhang X;Driscoll C;Bell A;Larson J;You JG;Weeks BT;Hernandez-Boussard T;Turner BE;Brooks JD
临床试验需要大量的资源，但只有在试验完成和结果传播后才能实现效益。我们全面评估了泌尿外科试验的早期终止、注册结果报告和试验发起人和亚专科的发表。我们评估了2007-2019年ClinicalTrials.gov上的试验注册和PubMed®/MEDLINE®的发表数据。使用Cox比例风险和完成后3年的结果报告或logistic回归来评估发起人或亚专业与早期停药之间的关系。在8636项试验中，3541项（41.0%）完成，999项（11.6%）终止。在完成的试验中，26.9%报告了结果，21.6%发表了结果。赞助商包括学术机构（53.1%）、行业（37.1%）和美国政府（9.8%）。学术资助的试验（调整后的风险比0.81,95% CI 0.69-0.96, p = 0.012）和政府资助的试验（调整后的风险比0.62,95% CI 0.49-0.78, p <0.001）比工业资助的试验更不可能提前终止。政府资助的试验更有可能报告（调整后OR为1.72,95% CI为1.17-2.54,p = 0.006）和发表（调整后OR为1.89,95% CI为1.23-2.89,p = 0.004）。学术资助的试验报告的可能性较小（调整后的OR为0.65，CI为0.48-0.88,p = 0.006），但发表的可能性较大（调整后的OR为1.72,95% CI为1.25-2.37,p <0.001）。这些结果在各亚专科之间相似。然而，泌尿外科更有可能早期停止（调整后的HR为2.00,95% CI为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为1.54,95% CI为1.13-2.11,p = 0.006），而男科发表结果的可能性较小（调整后的OR为0.53,95% CI为0.35-0.81,p = 0.003）。赞助者类型与试验完成和传播显著相关。政府资助的试验表现最好，而工业界和学术界资助的试验分别在完成和结果报告方面落后。亚专业的作用较小。缺乏传播仍然是泌尿外科试验的一个问题。
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 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.