On a class of optimal covariate-adjusted response adaptive designs for survival outcomes

Article Type

Research Article

Publication Title

Statistical Methods in Medical Research

Abstract

A class of optimal covariate-adjusted response adaptive procedures is developed for phase III clinical trials when the treatment response is a survival time and there is random censoring. The basic aim is to develop an allocation design by combining the ethical aspects with statistical precision in a reasonable way under the presence of covariate information. Considering minimisation of total hazards as the ethical requirement, the proposed procedure is assessed in terms of the assignment to the better treatment and the efficiency (i.e. power) to detect a small departure in treatment effectiveness. The applicability of the proposed methodology is also illustrated using a real data set.

First Page

2444

Last Page

2456

DOI

10.1177/0962280214524177

Publication Date

12-1-2016

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