Cheung Ying Kuen, Chappell Rick
Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, New York 10032, USA.
Biometrics. 2002 Sep;58(3):671-4. doi: 10.1111/j.0006-341x.2002.00671.x.
The continual reassessment method (CRM) is a sequential design used in phase I cancer trials to determine the maximal dose with acceptable toxicity. It has been established that the CRM is consistent under model misspecification but not generally. When the method does not converge to the target percentile, some dose-response models will be more sensitive than others in terms of how close the converged recommendation is to the target. In this article, we interpret the main condition under which the CRM is consistent and apply it to evaluate the sensitivity of the model used with the CRM. The technique presented is found to be a useful supplement to simulation when planning a phase I trial.
连续重新评估法(CRM)是一种用于一期癌症试验的序贯设计,以确定具有可接受毒性的最大剂量。已经确定,CRM在模型设定错误的情况下是一致的,但一般情况并非如此。当该方法未收敛到目标百分位数时,就收敛推荐与目标的接近程度而言,一些剂量反应模型会比其他模型更敏感。在本文中,我们解释了CRM一致的主要条件,并将其应用于评估与CRM一起使用的模型的敏感性。结果发现,所提出的技术在规划一期试验时是模拟的有用补充。