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Facilities for optimising and designing multi-arm multi-stage (MAMS) randomised controlled trials with binary outcomes

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  • Babak Choodari-Oskooei

    (MRC Clinical Trials Unit at UCL, University College London)

  • Daniel J. Bratton
  • Mahesh KB Parmar

Abstract

In this talk, we introduce two Stata programs nstagebin and nstagebinopt which can be used to facilitate the design of multi-arm multi-stage (MAMS) trials with binary outcomes. MAMS designs are a class of efficient and adaptive randomised clinical trials that have successfully been used in many disease areas, including cancer, TB, maternal health, COVID-19, and surgery. The nstagebinopt program finds a class of efficient “admissible” designs based on an optimality criterion using a systematic search procedure. The nstagebin command calculates the stagewise sample sizes, trial timelines, and the overall operating characteristics of MAMS design with binary outcomes. Both programs allow the use of Dunnett's correction to account for multiple testing. We also use the ROSSINI 2 MAMS design, an ongoing MAMS trial in surgical wound infection, to illustrate the capabilities of both programs. The new Stata programs facilitate the design of MAMS trials with binary outcomes where more than one research question can be addressed under one protocol.

Suggested Citation

  • Babak Choodari-Oskooei & Daniel J. Bratton & Mahesh KB Parmar, 2023. "Facilities for optimising and designing multi-arm multi-stage (MAMS) randomised controlled trials with binary outcomes," UK Stata Conference 2023 15, Stata Users Group.
    • Handle: RePEc:boc:lsug23:15
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