Department of Urology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
Department of Urology, University of Minnesota School of Medicine, Minneapolis, Minnesota.
J Urol. 2020 Oct;204(4):805-810. doi: 10.1097/JU.0000000000001072. Epub 2020 Apr 7.
Clinical trials serve as a critical source of information to guide evidence-based practices in urology. Conversely, trials that are abandoned consume significant resources and results are underreported in the literature.
ClinicalTrials.gov was queried for urology trials from 2006 to 2016. Trials were screened by 2 screeners for applicability to urology and disputes were resolved by a third independent reviewer. Overall 1,340 trials met final inclusion criteria (722 successful trials, 618 failed trials). Univariable analysis used Fisher's exact, chi-squared and Wilcoxon rank sum tests. Trial characteristics, including AUA (American Urological Association) section, phase, subspecialty, intervention type, source of funding and randomization were examined for association with failure using multivariable logistic regression.
Trial failure is associated with oncology subspecialty (adjusted odds ratio 2.25, 95% CI 1.60-3.18), infertility/andrology subspecialty (AOR 4.99, CI 1.60-17.61), device trials (AOR 1.64, CI 1.00-2.70) and combination funding by industry/government/grants (AOR 3.13, CI 2.21-4.48). Clinical trials in AUA sections were less likely to fail than international and multisectional trials. Among trials that failed, poor accrual was the primary reason for trial failure, comprising 41% of all failures. Other reasons for failure include inadequate budget (9%), sponsor cancellation (7%), poor interim results (7%) and toxicity (3%).
Despite their significance, many urological trials fail prematurely due to poor accrual. Complex features inherent to oncology, andrology/infertility, devices and multisectional trials pose significant barriers to success.
临床试验是指导泌尿外科循证实践的重要信息来源。相反，被放弃的试验会消耗大量资源，并且试验结果在文献中报道不足。
从 2006 年到 2016 年，在 ClinicalTrials.gov 上查询了泌尿外科试验。两名筛查员筛查了试验是否适用于泌尿外科，有争议的问题由第三名独立审查员解决。共有 1340 项试验符合最终纳入标准（722 项成功试验，618 项失败试验）。使用 Fisher's 精确检验、卡方检验和 Wilcoxon 秩和检验进行单变量分析。使用多变量逻辑回归分析试验特征，包括 AUA（美国泌尿外科学会）分会、阶段、亚专科、干预类型、资金来源和随机分组与失败的相关性。
试验失败与肿瘤学亚专科（调整后的优势比 2.25，95%CI 1.60-3.18）、不孕/男科亚专科（AOR 4.99，CI 1.60-17.61）、器械试验（AOR 1.64，CI 1.00-2.70）和工业/政府/赠款的组合资金有关（AOR 3.13，CI 2.21-4.48）。AUA 分会的临床试验比国际和多分会的临床试验失败的可能性更小。在失败的试验中，入组率低是试验失败的主要原因，占所有失败的 41%。其他失败原因包括预算不足（9%）、赞助商取消（7%）、中期结果不佳（7%）和毒性（3%）。
尽管意义重大，但许多泌尿外科试验由于入组率低而提前失败。肿瘤学、男科/不孕不育、器械和多分会试验固有的复杂特征是成功的重大障碍。
