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

Adrian Mander ()

Statistical Software Components from Boston College Department of Economics

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)

Language: Stata
Requires: Stata version 11
Keywords: Simon's two stage design; optimal design; minimax; single-arm trial (search for similar items in EconPapers)
Date: 2009-09-30, Revised 2012-01-17
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.
References: Add references at CitEc
Citations: View citations in EconPapers (1)

Downloads: (external link)
http://fmwww.bc.edu/repec/bocode/s/simon2stage.ado program code (text/plain)
http://fmwww.bc.edu/repec/bocode/s/simon2stage.sthlp help file (text/plain)

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:boc:bocode:s457081

Ordering information: This software item can be ordered from
http://repec.org/docs/ssc.php

Access Statistics for this software item

More software in Statistical Software Components from Boston College Department of Economics Boston College, 140 Commonwealth Avenue, Chestnut Hill MA 02467 USA. Contact information at EDIRC.
Bibliographic data for series maintained by Christopher F Baum ().