Adaptive designs for dose-finding based on efficacy-toxicity response

被引：86

作者：

Dragalin, V ^{[1
]}

Fedorov, V ^{[1
]}

机构：

[1] GlaxoSmithKline Inc, BDS, SDS, Res Stat Unit, Collegeville, PA 19426 USA

来源：

JOURNAL OF STATISTICAL PLANNING AND INFERENCE | 2006年 / 136卷 / 06期

关键词：

adaptive design; Cox bivariate binary model; dose-finding; Gumbel logistic regression model; information matrix; optimal experimental design; optimal safe dose; phase I/II clinical trials;

D O I：

10.1016/j.jspi.2005.08.005

中图分类号：

O21 [概率论与数理统计]; C8 [统计学];

学科分类号：

020208 ; 070103 ; 0714 ;

摘要：

We propose a new adaptive procedure for dose-finding in clinical trials when both efficacy and toxicity responses are available. We model the distribution of this bivariate binary endpoint using either Gumbel bivariate logistic regression or Cox bivariate binary model. In both cases, the analytic formulae for the Fisher information matrix are obtained, that form the basis for derivation of the locally optimal and adaptive designs. (c) 2005 Elsevier B.V. All rights reserved.

引用

页码：1800 / 1823

页数：24

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