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A covariate‐adjusted adaptive design for two‐stage clinical trials with survival data
Author(s) -
Bandyopadhyay Uttam,
Biswas Atanu,
Bhattacharya Rahul
Publication year - 2010
Publication title -
statistica neerlandica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.52
H-Index - 39
eISSN - 1467-9574
pISSN - 0039-0402
DOI - 10.1111/j.1467-9574.2010.00451.x
Subject(s) - covariate , inference , adaptive design , limiting , stage (stratigraphy) , statistics , mathematics , clinical trial , survival analysis , computer science , econometrics , mathematical optimization , medicine , artificial intelligence , engineering , mechanical engineering , paleontology , biology
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.