JCO：合理的临床试验——评价先验概率对二期临床试验的影响

2015-08-15 MedSci译 MedSci原创

注册审批是药物研发过程中最高潮的阶段。在对有前景的化合物进行细致筛选和优化之后，临床试验就是对其中最有希望成为上市药物的测试、评价。尽管有一个临床试验企业以及令人振奋的二期临床试验结果，处于研发阶段的肿瘤药只有极少数通过了注册审批。此外，临床医生时常依据二期临床试验数据作出治疗决策。因此，临床医生、研发人员以及注册审批部门需要对疗效显著的二期临床试验数据有着更为深入的理解。

注册审批是药物研发过程中最高潮的阶段。在对有前景的化合物进行细致筛选和优化之后，临床试验就是对其中最有希望成为上市药物的测试、评价。尽管有一个临床试验企业以及令人振奋的二期临床试验结果，处于研发阶段的肿瘤药只有极少数通过了注册审批。此外，临床医生时常依据二期临床试验数据作出治疗决策。因此，临床医生、研发人员以及注册审批部门需要对疗效显著的二期临床试验数据有着更为深入的理解。

研究人员假设各种胃肠癌药物通过最终药物审批的先验概率有着显著差异。研究人员对1999年至2004年间的二期临床试验进行了系统性检索。在所有检索结果中，有317项二期临床试验被确定并跟踪了12.5年（中位时间）。三期临床结束后，最终新药应用批准比例在0%-34.8%之间。其中，胰腺癌药物通过审批比例为零（共有45种药物），结肠腺癌药物通过率为最高的34.8%（24/69）。最终通过审批的药物的比例和处于研究中的疾病是一致的。所有试验的中值一型错误为0.05，二型错误为0.1。通过使用各种疾病的监测一型中值错误，二期临床试验有阳性预测值，范围在小于1%-90%，这是依赖于癌症的最初部位。

此次研究表明，不同的胃肠癌的二期临床试验有着显著的药物批准先验概率。将先验概率合并进入临床试验设计中或许可以更有效地设计试验并且更深入理解二期临床试验。

原始出处：
Halperin DM, Lee JJ, Dagohoy CG, Yao JC.. Rational Clinical Experiment: Assessing Prior Probability and Its Impact on the Success of Phase II Clinical Trials. J Clin Oncol. 2015 Aug 10. pii: JCO.2015.61.4362

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2017-02-16 虈亣靌

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2016-04-22 忠诚向上

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2016-04-22 忠诚向上

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值得学习

180 0
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2016-04-22 忠诚向上

值得学习

152 0
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2016-04-22 忠诚向上

值得学习

127 0
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2016-04-22 忠诚向上

值得学习

116 0
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2016-04-22 忠诚向上

值得学习

120 0
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2016-04-22 忠诚向上

值得学习

124 0
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