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Publication Detail

Title: Unified exact design with early stopping rules for single arm clinical trials with multiple endpoints.

Authors: Wei, Wei; Esserman, Denise; Kane, Michael; Zelterman, Daniel

Published In Stat Methods Med Res, (2021 07)

Abstract: Adaptive designs are gaining popularity in early phase clinical trials because they enable investigators to change the course of a study in response to accumulating data. We propose a novel design to simultaneously monitor several endpoints. These include efficacy, futility, toxicity and other outcomes in early phase, single-arm studies. We construct a recursive relationship to compute the exact probabilities of stopping for any combination of endpoints without the need for simulation, given pre-specified decision rules. The proposed design is flexible in the number and timing of interim analyses. A R Shiny app with user-friendly web interface has been created to facilitate the implementation of the proposed design.

PubMed ID: 34159859 Exiting the NIEHS site

MeSH Terms: Computer Simulation; Medical Futility*; Probability; Research Design*

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