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SIMON2STAGE: Stata module to to compute the design parameters for a Simon two-stage design

Author

Listed:
  • Adrian Mander

Programming Language

Stata

Abstract

The Simon two stage design is a single arm study with an interim analysis. The main purpose of this design is to investigate whether an intervention works or not and to stop the study early for futility. Under the null hypothesis the probability of a success is p0, this is usually taken as the probability of success for the current standard treatment. The probability of a success in this study, p, is tested using the null hypothesis H0:p=p0 versus the alternative hypothesis H1:p>=p1. The probability of success for the alternative hypothesis is fixed to be a pre-specified value p1, where p1>p0. The Simon two stage design consists of studying n1 participants in a first stage and the study stops if there are r1 or fewer responders to the intervention. If there are more than r1 responders in the first stage then the study continues until n participants in total are studied. Then the null hypothesis is not rejected if there are r or fewer responders. Each design must satisfy the type 1 (alpha) and type 2 (beta) errors. The probability of not rejecting H0 can be calculated conditional on any p and let this function be R(p). The design must therefore satisfy the constraints R(p0)>=1-alpha and R(p1)

Suggested Citation

  • Adrian Mander, 2009. "SIMON2STAGE: Stata module to to compute the design parameters for a Simon two-stage design," Statistical Software Components S457081, Boston College Department of Economics, revised 17 Jan 2012.
    • Handle: RePEc:boc:bocode:s457081
    Note: This module should be installed from within Stata by typing "ssc install simon2stage". The module is made available under terms of the GPL v3 (https://www.gnu.org/licenses/gpl-3.0.txt). Windows users should not attempt to download these files with a web browser.
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    Download full text from publisher

    File URL: http://fmwww.bc.edu/repec/bocode/s/simon2stage.ado
    File Function: program code
    Download Restriction: no
    File URL: http://fmwww.bc.edu/repec/bocode/s/simon2stage.sthlp
    File Function: help file
    Download Restriction: no
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    Citations

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    Cited by:

    1. Cornelia U. Kunz & Meinhard Kieser, 2011. "Simon's minimax and optimal and Jung's admissible two-stage designs with or without curtailment," Stata Journal, StataCorp LP, vol. 11(2), pages 240-254, June.

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