Simulating clinical trial designs

Adrian Mander
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Adrian Mander: Cardiff University

Biostatistics and Epidemiology Virtual Symposium 2022 from Stata Users Group

Abstract: Clinical trial designs are increasingly becoming more complex and therefore do not have simple formulae for determining the sample size and operating characteristics of the design. In the absence of formulae, simulation is the tool of choice, but often trial statisticians are not fully aware of how to do the simulations. Trial simulations in Stata are easily achieved by writing many lines of code, but I introduce a new command, tacts, that attempts to run the simulations within a single line of code. This command will handle many different types of design, such as MAMS, trials with longitudinal outcomes, sample size reestimation, multiple-outcome trials with multiplicity correction, and adaptive randomization. The command will also be able to gather the output of the simulations and produce a summary table of the results. To handle the complexity of all of these trials requires a complex syntax that is very flexible.

Date: 2022-06-25
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Persistent link: https://EconPapers.repec.org/RePEc:boc:biep22:01

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