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To add or not to add a new treatment arm to a multiarm study : a decision‐theoretic framework
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Lee, Kim May, Wason, James and Stallard, Nigel (2019) To add or not to add a new treatment arm to a multiarm study : a decision‐theoretic framework. Statistics in Medicine . doi:10.1002/sim.8194 ISSN 0277-6715.
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Official URL: http://dx.doi.org/10.1002/sim.8194
Abstract
Multiarm clinical trials, which compare several experimental treatments against control, are frequently recommended due to their efficiency gain. In practise, all potential treatments may not be ready to be tested in a phase II/III trial at the same time. It has become appealing to allow new treatment arms to be added into on‐going clinical trials using a “platform” trial approach. To the best of our knowledge, many aspects of when to add arms to an existing trial have not been explored in the literature. Most works on adding arm(s) assume that a new arm is opened whenever a new treatment becomes available. This strategy may prolong the overall duration of a study or cause reduction in marginal power for each hypothesis if the adaptation is not well accommodated. Within a two‐stage trial setting, we propose a decision‐theoretic framework to investigate when to add or not to add a new treatment arm based on the observed stage one treatment responses. To account for different prospect of multiarm studies, we define utility in two different ways; one for a trial that aims to maximise the number of rejected hypotheses; the other for a trial that would declare a success when at least one hypothesis is rejected from the study. Our framework shows that it is not always optimal to add a new treatment arm to an existing trial. We illustrate a case study by considering a completed trial on knee osteoarthritis.
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 > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Statistics and Epidemiology Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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Library of Congress Subject Headings (LCSH): | Clinical trials, Osteoarthritis, Knee -- Diseases | |||||||||
Journal or Publication Title: | Statistics in Medicine | |||||||||
Publisher: | John Wiley & Sons Ltd. | |||||||||
ISSN: | 0277-6715 | |||||||||
Official Date: | 21 May 2019 | |||||||||
Dates: |
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DOI: | 10.1002/sim.8194 | |||||||||
Status: | Peer Reviewed | |||||||||
Publication Status: | Published | |||||||||
Access rights to Published version: | Open Access (Creative Commons) | |||||||||
Date of first compliant deposit: | 24 May 2019 | |||||||||
Date of first compliant Open Access: | 29 May 2019 | |||||||||
RIOXX Funder/Project Grant: |
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