Improved up-and-down designs for phase I trials

被引:84
作者
Ivanova, A
Montazer-Haghighi, A
Mohanty, G
Durham, SD
机构
[1] Univ N Carolina, Dept Biostat, Chapel Hill, NC 27599 USA
[2] Benedict Coll, Dept Math & Comp Sci, Columbia, SC 29204 USA
[3] McMaster Univ, Dept Math & Stat, Hamilton, ON L85 4K1, Canada
[4] Univ S Carolina, Dept Stat, Columbia, SC 29208 USA
关键词
phase I trial; dose finding; up-and-down design; continual reassessment method; CONTINUAL REASSESSMENT METHOD; CLINICAL-TRIALS; REGRESSION; CANCER;
D O I
10.1002/sim.1336
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
We consider several designs from the family of up-and-down rules for the sequential allocation of dose levels to subjects in a dose-response study, We show that an up-and-down design can be improved by using more information than the most recent response. For example, the A-in-a-row rule uses up to the k most recent responses. We introduce a new design, the Narayana rule, which uses a local estimate of the probability of toxicity calculated from all previous responses. For the Narayana rule, as the sample size gets large, the probability of assignment goes to zero for dose levels not among the two (or three) closest to the target. Different estimators of the target dose are compared. We find that the isotonic regression estimator is Superior to other estimators for small to moderate sample sizes. Copyright (C) 2003 John Wiley Sons. Ltd.
引用
收藏
页码:69 / 82
页数:14
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