Facilities for optimizing and designing multiarm multistage (MAMS) randomized controlled trials with binary outcomes

MAMS designs are a class of efficient and adaptive randomized clinical trials that have successfully been used in many disease areas, including cancer, TB, maternal health, COVID-19, and surgery. The nstagebinopt command 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 commands facilitate the design of MAMS trials with binary outcomes where more than one research question can be addressed under one protocol.

Reference:
Choodari-Oskooei B., D. J. Bratton, and M. Parmar. 2023. Facilities for optimizing and designing multi-arm multistage (MAMS) randomised controlled trials with binary outcomes. Stata Journal. Under review.