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Group sequential clinical trial designs for normally distributed outcome variables

Author

Listed:
  • Michael Grayling

    (MRC Biostatistics Unit, University of Cambridge)

  • James Wason

    (MRC Biostatistics Unit, University of Cambridge)

  • Adrian Mander

    (MRC Biostatistics Unit, University of Cambridge)

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.

Suggested Citation

  • Michael Grayling & James Wason & Adrian Mander, 2017. "Group sequential clinical trial designs for normally distributed outcome variables," United Kingdom Stata Users' Group Meetings 2017 15, Stata Users Group.
  • Handle: RePEc:boc:usug17:15
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