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Using dichotomized survival data to construct a prior distribution for a Bayesian seamless Phase II/III clinical trial
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Duputel, Benjamin, Stallard, Nigel, Montestruc, François, Zohar, Sarah and Ursino, Moreno (2023) Using dichotomized survival data to construct a prior distribution for a Bayesian seamless Phase II/III clinical trial. Statistical Methods in Medical Research, 32 (5). pp. 963-977. doi:10.1177/09622802231160554 ISSN 1477-0334.
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Official URL: https://doi.org/10.1177/09622802231160554
Abstract
Master protocol designs allow for simultaneous comparison of multiple treatments or disease subgroups. Master protocols can also be designed as seamless studies, in which two or more clinical phases are considered within the same trial. They can be divided into two categories: operationally seamless, in which the two phases are separated into two independent studies, and inferentially seamless, in which the interim analysis is considered an adaptation of the study. Bayesian designs are scarcely studied. Our aim is to propose and compare Bayesian operationally seamless Phase II/III designs using a binary endpoint for the first stage and a time-to-event endpoint for the second stage. At the end of Phase II, arm selection is based on posterior (futility) and predictive (selection) probabilities. The results of the first phase are then incorporated into prior distributions of a time-to-event model. Simulation studies showed that Bayesian operationally seamless designs can approach the inferentially seamless counterpart, allowing for an increasing simulated power with respect to the operationally frequentist design.
Item Type: | Journal Article | ||||||||
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Subjects: | R Medicine > R Medicine (General) | ||||||||
Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School | ||||||||
SWORD Depositor: | Library Publications Router | ||||||||
Library of Congress Subject Headings (LCSH): | Clinical trials -- Statistical methods, Drugs -- Testing -- Statistical methods, Bayesian statistical decision theory, Clinical trials -- Design -- Research | ||||||||
Journal or Publication Title: | Statistical Methods in Medical Research | ||||||||
Publisher: | SAGE Publications | ||||||||
ISSN: | 1477-0334 | ||||||||
Official Date: | May 2023 | ||||||||
Dates: |
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Volume: | 32 | ||||||||
Number: | 5 | ||||||||
Page Range: | pp. 963-977 | ||||||||
DOI: | 10.1177/09622802231160554 | ||||||||
Status: | Peer Reviewed | ||||||||
Publication Status: | Published | ||||||||
Reuse Statement (publisher, data, author rights): | Duputel B, Stallard N, Montestruc F, Zohar S, Ursino M. Using dichotomized survival data to construct a prior distribution for a Bayesian seamless Phase II/III clinical trial. Statistical Methods in Medical Research. 2023;0(0). doi:10.1177/09622802231160554 Copyright © The Author(s) 2023.. Reprinted by permission of SAGE Publications. https://doi.org/10.1177/09622802231160554 | ||||||||
Access rights to Published version: | Restricted or Subscription Access | ||||||||
Copyright Holders: | © The Author(s) 2023. | ||||||||
Date of first compliant deposit: | 3 May 2023 | ||||||||
Date of first compliant Open Access: | 3 May 2023 |
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