Group sequential clinical trial designs for normally distributed outcome variables

Michael Grayling, James Wason () and Adrian Mander ()
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James Wason: MRC Biostatistics Unit, University of Cambridge

United Kingdom Stata Users' Group Meetings 2017 from Stata Users Group

Abstract: In a group sequential trial, accumulated data are analysed at numerous time-points in order to allow early decisions to be made about a hypothesis of interest. These designs have historically been recommended for their ethical, administrative and economic benefits, and indeed have a long history of use in clinical research. In this presentation, we begin by discussing the theory behind these designs. Then, we describe 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. We conclude by discussing the many possible future extensions of this work.

Date: 2017-09-14
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Persistent link: https://EconPapers.repec.org/RePEc:boc:usug17:15

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