Lin Timothy A, Fuller Clifton David, Verma Vivek, Mainwaring Walker, Espinoza Andres F, Miller Austin B, Jethanandani Amit, Pasalic Dario, Das Prajnan, Minsky Bruce D, Thomas Charles R, Fogelman David R, Subbiah Vivek, Subbiah Ishwaria M, Ludmir Ethan B
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, USA.
Department of Radiation Oncology and Molecular Sciences, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 401 N. Broadway Baltimore, MD 21287, USA.
Cancers (Basel). 2020 Sep 16;12(9):2636. doi: 10.3390/cancers12092636.
The pace of clinical trial data generation and publication is an area of interest within clinical oncology; however, little is known about the dynamics and covariates of time to reporting (TTR) of trial results. To assess these, ClinicalTrials.gov was queried for phase three clinical trials for patients with metastatic solid tumors, and the factors associated with TTR from enrollment completion to publication were analyzed. Based on the 319 included trials, cooperative-group-sponsored trials were reported at a slower rate than non-cooperative-group trials (median 37.5 vs. 31.0 months; < 0.001), while industry-funded studies were reported at a faster rate than non-industry-supported trials (31.0 vs. 40.0 months; = 0.005). Furthermore, successful trials (those meeting their primary endpoint) were reported at a faster rate than unsuccessful studies (27.5 vs. 36.0 months; < 0.001). Multivariable analysis confirmed that industry funding was independently associated with a shorter TTR ( = 0.006), while cooperative group sponsorship was not associated with a statistically significant difference in TTR ( = 0.18). These data underscore an opportunity to improve cooperative group trial efficiency by reducing TTR.
临床试验数据生成和发表的速度是临床肿瘤学领域关注的一个方面；然而，对于试验结果报告时间（TTR）的动态变化和协变量知之甚少。为了评估这些情况，我们在ClinicalTrials.gov上查询了转移性实体瘤患者的三期临床试验，并分析了从入组完成到发表的TTR相关因素。基于纳入的319项试验，合作组发起的试验报告速度比非合作组试验慢（中位数分别为37.5个月和31.0个月；<0.001），而行业资助的研究报告速度比非行业支持的试验快（31.0个月和40.0个月；=0.005）。此外，成功的试验（达到其主要终点的试验）报告速度比未成功的研究快（27.5个月和36.0个月；<0.001）。多变量分析证实，行业资助与较短的TTR独立相关（=0.006），而合作组发起与TTR的统计学显著差异无关（=0.18）。这些数据强调了通过缩短TTR来提高合作组试验效率的机会。
