Accrual Experience of National Cancer Institute Cooperative Group Phase III Trials Activated From 2000 to 2007
Accrual Experience of National Cancer Institute Cooperative Group Phase III Trials Activated From 2000 to 2007
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DOI：
10.1200/jco.2010.31.5382
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发表时间：
2010-12-10
影响因子：
45.3
通讯作者：
Abrams, Jeffrey S.
中科院分区：
文献类型：
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作者：
Korn, Edward L.;Freidlin, Boris;Abrams, Jeffrey S.
最近的报告表明，40%或更多的美国国家癌症研究所（NCI）赞助的合作组III期试验未能实现其累积目标。我们详细研究的权责发生制经验的合作组III期trials.Patients和MethodsAll合作组III期试验激活2000年至2007年进行了检查，他们的权责发生制经验。对于停止累积的试验，其累积目标< 90%，记录累积< 90%的原因。我们专注于试验，结束了< 90%的应计率，因为不充分的应计率，而不是其他原因，如中期监测分析，由一个独立的数据监测委员会，停止试验早期，因为一个治疗显然是优越的上级。我们预计，由于累积率不足，这些试验中有22.0%的累积率将< 90%。我们预计最终将有176，627例患者参与191项试验（目前的累计人数为154，579人），其中2，991例患者将参与因累计率不足而累计率< 90%的试验（1.7%）。非儿科癌症试验的相应比例分别为26.7%和2.0%。结论我们发现，不充分的累积率并不像以前报道的那样高，只有一小部分患者参加了因不充分的累积率而导致不充分的累积的试验。NCI已经实施了新的程序，以减少未能达到其累积目标的试验数量，并尽量减少这些试验中累积的患者数量。
PurposeRecent reports have suggested that 40% or more of National Cancer Institute (NCI) -sponsored Cooperative Group phase III trials failed to achieve their accrual goals. We examine in detail the accrual experience of the Cooperative Group phase III trials.Patients and MethodsAll Cooperative Group phase III trials activated from 2000 to 2007 were examined for their accrual experience. For trials that stopped accrual with < 90% of their accrual goal, the reasons for having < 90% accrual were documented. We focus on trials that ended with < 90% accrual because of inadequate accrual rates rather than for other reasons, such as an interim monitoring analysis by an independent data monitoring committee that stops the trial early because one treatment is clearly superior.ResultsThere were 191 trials activated from 2000 to 2007. We project that 22.0% of these trials will have < 90% accrual because of inadequate accrual rates. We project that there will be 176,627 patients eventually accrued on the 191 trials (current accrual, 154,579) and that 2,991 of these patients will be on trials that have < 90% accrual because of inadequate accrual rates (1.7%). For nonpediatric cancer trials, the corresponding percentages are 26.7% and 2.0%.ConclusionWe find that insufficient accrual rates are not as high as previously reported and that only a small proportion of patients were enrolled on trials that ended with insufficient accrual because of an inadequate accrual rate. NCI has implemented new procedures to reduce the number of trials that fail to reach their accrual goals and to minimize the number of patients accrued on these trials.