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Group Sequential Clinical Trial Designs for Normally Distributed Outcome Variables

Accepted version
Peer-reviewed

Type

Article

Change log

Authors

Grayling, MJ 
Mander, AP 

Abstract

In a group sequential clinical trial, accumulated data are analysed at numerous time-points in order to allow early decisions about a hypothesis of interest. These designs have historically been recommended for their ethical, administrative and economic bene fits. In this work, we discuss a collection of new Stata commands for computing the stopping boundaries and required group size of various classical group sequential designs, assuming a normally distributed outcome variable. Following this, we demonstrate how the performance of several designs can be compared graphically.

Description

Keywords

clinical trial design, doubletriangular, group sequential, haybittlepeto, innerwedge, powerfamily, st0529, triangular, wangtsiatis

Journal Title

Stata Journal

Conference Name

Journal ISSN

1536-867X
1536-8734

Volume Title

18

Publisher

DPC Nederland
Sponsorship
Wellcome Trust (099770/Z/12/Z)
MRC (unknown)
MRC (unknown)