A covariate-adjusted adaptive design for two-stage clinical trials with survival data

被引：14
|
作者：
Bandyopadhyay, Uttam [1 ]
Biswas, Atanu [2 ]
Bhattacharya, Rahul [3 ]
机构：
[1] Univ Calcutta, Dept Stat, Kolkata 700019, W Bengal, India
[2] Indian Stat Inst, Appl Stat Unit, Kolkata 700108, India
[3] W Bengal State Univ, Dept Stat, Kolkata 700126, India
来源：
STATISTICA NEERLANDICA | 2010年 / 64卷 / 02期
关键词：
censoring; covariate-adjusted adaptive allocation; ethics; optimality; survival data; RANDOMLY CENSORED-DATA; KOZIOL-GREEN MODEL; PROPORTIONAL HAZARDS MODEL; BIASED-COIN DESIGNS; MAXIMUM-LIKELIHOOD-ESTIMATION; NORMAL RESPONSES; EXPONENTIAL SURVIVAL; FISHER INFORMATION; STRONG CONSISTENCY; SAMPLE-SIZE;
D O I：
10.1111/j.1467-9574.2010.00451.x
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：
A randomized two-stage adaptive design is proposed and studied for allocation of patients to treatments and comparison in a phase III clinical trial with survival time as treatment responses. We consider the possibility of several covariates in the design and analysis. Several exact and limiting properties of the design and the follow-up inference are studied, both numerically and theoretically. The applicability of the proposed methodology is illustrated by using some real data.
引用
收藏
页码：202 / 226
页数：25
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