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Comparison of Bayesian and frequentist group-sequential clinical trial designs
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Stallard, Nigel, Todd, Susan, Ryan, Elizabeth G. and Gates, Simon (2020) Comparison of Bayesian and frequentist group-sequential clinical trial designs. BMC Medical Research Methodology, 20 (1). 4 . doi:10.1186/s12874-019-0892-8 ISSN 1471-2288.
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Official URL: http://dx.doi.org/10.1186/s12874-019-0892-8
Abstract
Background
There is a growing interest in the use of Bayesian adaptive designs in late-phase clinical trials. This includes the use of stopping rules based on Bayesian analyses in which the frequentist type I error rate is controlled as in frequentist group-sequential designs.
Methods
This paper presents a practical comparison of Bayesian and frequentist group-sequential tests. Focussing on the setting in which data can be summarised by normally distributed test statistics, we evaluate and compare boundary values and operating characteristics.
Results
Although Bayesian and frequentist group-sequential approaches are based on fundamentally different paradigms, in a single arm trial or two-arm comparative trial with a prior distribution specified for the treatment difference, Bayesian and frequentist group-sequential tests can have identical stopping rules if particular critical values with which the posterior probability is compared or particular spending function values are chosen. If the Bayesian critical values at different looks are restricted to be equal, O’Brien and Fleming’s design corresponds to a Bayesian design with an exceptionally informative negative prior, Pocock’s design to a Bayesian design with a non-informative prior and frequentist designs with a linear alpha spending function are very similar to Bayesian designs with slightly informative priors.This contrasts with the setting of a comparative trial with independent prior distributions specified for treatment effects in different groups. In this case Bayesian and frequentist group-sequential tests cannot have the same stopping rule as the Bayesian stopping rule depends on the observed means in the two groups and not just on their difference. In this setting the Bayesian test can only be guaranteed to control the type I error for a specified range of values of the control group treatment effect.
Conclusions
Comparison of frequentist and Bayesian designs can encourage careful thought about design parameters and help to ensure appropriate design choices are made.
Item Type: | Journal Article | ||||||
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Subjects: | Q Science > QA Mathematics R Medicine > R Medicine (General) |
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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): | Sequential analysis, Bayesian statistical decision theory, Clinical trials -- Design | ||||||
Journal or Publication Title: | BMC Medical Research Methodology | ||||||
Publisher: | BioMed Central Ltd. | ||||||
ISSN: | 1471-2288 | ||||||
Official Date: | 7 January 2020 | ||||||
Dates: |
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Volume: | 20 | ||||||
Number: | 1 | ||||||
Article Number: | 4 | ||||||
DOI: | 10.1186/s12874-019-0892-8 | ||||||
Status: | Peer Reviewed | ||||||
Publication Status: | Published | ||||||
Access rights to Published version: | Open Access (Creative Commons) | ||||||
Date of first compliant deposit: | 10 January 2020 | ||||||
Date of first compliant Open Access: | 10 January 2020 | ||||||
RIOXX Funder/Project Grant: |
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