Blinded sample size re-estimation in 2 x 2 crossover trial

被引:0
作者
Banerjee, Kaustav [1 ]
Chattopadhyay, Gaurangadeb [2 ]
Banerjee, Tathagata [3 ]
机构
[1] Indian Inst Management Lucknow, Lucknow, India
[2] Univ Calcutta, Kolkata, India
[3] Dhirubhai Ambani Inst Informat & Commun Technol, Gandhinagar, India
关键词
Crossover trial; risk of unblinding; sample size re-estimation; 2-STAGE BIOEQUIVALENCE; NUISANCE-PARAMETER; VARIANCE; DESIGNS; POWER;
D O I
10.1080/00949655.2024.2408357
中图分类号
TP39 [计算机的应用];
学科分类号
081203 ; 0835 ;
摘要
Blinded sample size re-estimation is often considered to have realistic estimate of the required sample size, during the mid-course of a trial, without compromising the trial's integrity, to save a trial from being under or over-powered. We consider blinded sample size re-estimation, in the context of $ 2 \times 2 $ 2x2 crossover trial, following permuted block randomization. The underlying likelihood function suffers from identifiability problems. Blinded re-estimation procedures are prescribed under this setting and it is shown that the associated risk of unblinding may not always be negligible.
引用
收藏
页码:4001 / 4018
页数:18
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