A sense of urgency: Evaluating the link between clinical trial development time and the accrual performance of cancer therapy evaluation program (NCI-CTEP) sponsored studies.
A sense of urgency: Evaluating the link between clinical trial development time and the accrual performance of cancer therapy evaluation program (NCI-CTEP) sponsored studies.
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DOI：
10.1158/1078-0432.ccr-10-0133
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发表时间：
2010-11-15
期刊：
影响因子：
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通讯作者：
Dilts DM
中科院分区：
文献类型：
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作者：
Cheng SK;Dietrich MS;Dilts DM
肿瘤学临床试验累积的激活后障碍有详细记录;但是，试验开始前的潜在障碍没有记录。我们调查了一个这样的障碍：试验开发时间。对2000-2004年期间启动的所有治疗性、非儿科I期、I/II期、II期和III期研究的国家癌症研究所癌症治疗评价项目（CTEP）申办的试验进行了为期8年的研究（n=419）。成功的试验是那些达到100%最低累积目标的试验。研究开始时间是指从初始CTEP提交到试验激活的日历时间。使用多变量逻辑回归分析来计算未调整和调整后的比值比，控制研究阶段和预期应计费用的大小。37.9在CTEP批准的肿瘤学试验中，221例未能达到最低应计目标，70.8%（n=14）的III期试验导致应计不良。共有16474例患者（42.5%的应计费用）参加了无法达到预计最低应计费用目标的研究。与中位开发时间为12-18个月的试验相比，需要少于12个月开发的试验更有可能实现累积目标（比值比，2.15; 95% CI，1.29-3.57，P=0.003）。与中位开发时间的试验相比，需要超过24个月开发时间的试验实现累积目标的可能性显著降低（比值比，0.40; 95%CI，0.20-0.78，P=0.011）。很大比例的肿瘤临床试验没有达到最低预期应计利润。试验开发时间似乎是成功实现最低累积目标的可能性的一个重要预测因素。
Post-activation barriers to oncology clinical trial accruals are well documented; however, potential barriers prior to trial opening are not. We investigate one such barrier: trial development time. National Cancer Institute Cancer Therapy Evaluation Program (CTEP)-sponsored trials for all therapeutic, non-pediatric Phase I, I/II, II, and III studies activated between 2000–2004 were investigated for an eight-year period (n=419). Successful trials were those achieving 100% of minimum accrual goal. Time to open a study was the calendar time from initial CTEP submission to trial activation. Multivariate logistic regression analysis was used to calculate unadjusted and adjusted odds ratios, controlling for study phase and size of expected accruals. 37.9 percent (n=221) of CTEP-approved oncology trials failed to attain the minimum accrual goals, with 70.8 percent (n=14) of Phase III trials resulting in poor accrual. A total of 16474 patients (42.5% of accruals) accrued to those studies that were unable to achieve the projected minimum accrual goal. Trials requiring less than 12 months development were significantly more likely to achieve accrual goals (odds ratio, 2.15; 95% CI, 1.29–3.57, P=0.003) than trials with the median development time of 12–18 months. Trials requiring a development time of greater than 24 months were significantly less likely of achieving accrual goals (odds ratio, 0.40; 95% CI, 0.20–0.78, P=0.011) than trials with the median development time. A large percentage of oncology clinical trials do not achieve minimum projected accruals. Trial development time appears to be one important predictor of the likelihood of successfully achieving the minimum accrual goals.