Doctoral Program in Medical Sciences, Graduate School of Comprehensive Human Sciences, University of Tsukuba, Tsukuba, Ibaraki, Japan.
Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Trials. 2024 Oct 8;25(1):665. doi: 10.1186/s13063-024-08508-9.
Poor patient accrual can delay reporting of clinical trials and, consequently, the development of new treatments. For reducing the risk of additional resource requirements, a method for setting planned accrual periods with minimal deviation from the actual accrual periods is desirable. Risk factors for poor patient accrual and the appropriate method of estimating the required accrual period for timely completion of clinical trials were evaluated using the data of trials conducted by the Japan Clinical Oncology Group.
The study included 199 trials that started patient accrual between January 1, 1990, and June 30, 2021. The explanatory variables included factors that could be evaluated prior to trial commencement. We also evaluated whether the estimation methods for accrual pace could lead to completion within the planned accrual period.
Approximately 23.6% of trials were completed within the planned accrual period. The risk factors for trial extension included planned accrual periods > 3 years (reference group: ≤ 3 years, odds ratio [OR] 0.37, 95% confidence interval [CI]: 0.15-0.92, P = 0.033) and stratified trial design (reference group: nonrandomized phase II trials, nonrandomized phase III trial [OR: 3.28, 95% CI: 0.99-10.9, P = 0.051], randomized phase II trial [OR: 3.91, 95% CI: 0.75-20.30, P = 0.105], and randomized phase III trial [OR: 9.29, 95% CI: 3.39-25.40, P < 0.001]). The method of estimating the accrual pace based on past clinical trials facilitated timely completion of the trial (OR: 3.51; 95% CI: 1.73-7.10, P < 0.001), unlike the estimation method based on survey evaluation of the accrual pace for participating institutions (OR: 1.12, 95% CI: 0.56-2.26, P = 0.751). Furthermore, the discrepancy between planned and actual accrual periods was minimal when using the methods of considering the accrual pace of past clinical trials.
Considering the accrual pace of past clinical trials is useful for estimating the required accrual period if data from past trials are available. When conducting a survey, it is necessary to be cautious of overestimating the cases at each facility.
临床试验的患者入组率低可能会延迟报告，从而影响新疗法的研发。为了降低额外资源需求的风险，需要一种能够最小化实际入组与计划入组之间偏差的设定计划入组期的方法。本研究使用日本临床肿瘤学组开展的临床试验数据，评估了导致患者入组率低的风险因素以及及时完成临床试验所需的预估入组期的适当方法。
本研究纳入了 199 项于 1990 年 1 月 1 日至 2021 年 6 月 30 日期间开始患者入组的试验。解释变量包括试验开始前可评估的因素。我们还评估了入组速度的预估方法是否能够使试验在计划入组期内完成。
大约 23.6%的试验在计划入组期内完成。试验延长的风险因素包括计划入组期超过 3 年（参考组：≤3 年，比值比 [OR] 0.37，95%置信区间 [CI]：0.15-0.92，P=0.033）和分层试验设计（参考组：非随机化 II 期试验，非随机化 III 期试验 [OR：3.28，95%CI：0.99-10.9，P=0.051]，随机化 II 期试验 [OR：3.91，95%CI：0.75-20.30，P=0.105]，以及随机化 III 期试验 [OR：9.29，95%CI：3.39-25.40，P<0.001]）。基于过去临床试验的入组速度预估方法有助于及时完成试验（OR：3.51；95%CI：1.73-7.10，P<0.001），而基于参与机构入组速度调查评估的预估方法则不然（OR：1.12，95%CI：0.56-2.26，P=0.751）。此外，如果有过去临床试验的数据，考虑过去临床试验的入组速度的方法可以最小化计划入组期和实际入组期之间的差异。
如果有过去临床试验的数据，可以考虑使用过去临床试验的入组速度来估计所需的入组期。在进行调查时，需要谨慎避免高估每个机构的病例数。
