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

Choodari-Oskooei, Babak; Bratton, Daniel J; Parmar, Mahesh KB; (2023) Facilities for optimizing and designing multiarm multistage (MAMS) randomized controlled trials with binary outcomes. The Stata Journal , 23 (3) pp. 774-798. 10.1177/1536867x231196295. Green open access

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Abstract

We introduce two commands, nstagebin and nstagebinopt, that can be used to facilitate the design of multiarm multistage (MAMS) 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, tuberculosis, 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 overall operating characteristics of MAMS designs with binary outcomes. Both commands 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 commands. The new commands facilitate the design of MAMS trials with binary outcomes where more than one research question can be addressed under one protocol.

Type: Article
Title: Facilities for optimizing and designing multiarm multistage (MAMS) randomized controlled trials with binary outcomes
Open access status: An open access version is available from UCL Discovery
DOI: 10.1177/1536867x231196295
Publisher version: https://doi.org/10.1177/1536867x231196295
Language: English
Additional information: Copyright © StataCorp LLC 2023. This article is distributed under the terms of the Creative Commons Attribution 4.0 License (https://creativecommons.org/licenses/by/4.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
Keywords: st0728, nstagebin, nstagebinopt, multiarm multistage, MAMS, familywise type I error rate, FWER, α functions, adaptive designs
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
URI: https://discovery.ucl.ac.uk/id/eprint/10177747
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