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Decision-theoretic designs for a series of trials with correlated treatment effects using the Sarmanov multivariate beta-binomial distribution
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Hee, Siew Wan, Parsons, Nicholas R. and Stallard, Nigel (2018) Decision-theoretic designs for a series of trials with correlated treatment effects using the Sarmanov multivariate beta-binomial distribution. Biometrical Journal, 60 (2). pp. 232-245. doi:10.1002/bimj.201600202
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Official URL: https://doi.org/10.1002/bimj.201600202
Abstract
The motivation for the work in this article is the setting in which a number of treatments are available for evaluation in phase II clinical trials and where it may be infeasible to try them concurrently because the intended population is small. This paper introduces an extension of previous work on decision-theoretic designs for a series of phase II trials. The program encompasses a series of sequential phase II trials with interim decision making and a single two-arm phase III trial. The design is based on a hybrid approach where the final analysis of the phase III data is based on a classical frequentist hypothesis test, whereas the trials are designed using a Bayesian decision-theoretic approach in which the unknown treatment effect is assumed to follow a known prior distribution. In addition, as treatments are intended for the same population it is not unrealistic to consider treatment effects to be correlated. Thus, the prior distribution will reflect this. Data from a randomized trial of severe arthritis of the hip are used to test the application of the design. We show that the design on average requires fewer patients in phase II than when the correlation is ignored. Correspondingly, the time required to recommend an efficacious treatment for phase III is quicker.
| 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): | Clinical trials -- Methodology, Bayesian statistical decision theory | ||||||||
| Journal or Publication Title: | Biometrical Journal | ||||||||
| Publisher: | Wiley - V C H Verlag | ||||||||
| ISSN: | 0323-3847 | ||||||||
| Official Date: | March 2018 | ||||||||
| Dates: |
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| Volume: | 60 | ||||||||
| Number: | 2 | ||||||||
| Page Range: | pp. 232-245 | ||||||||
| DOI: | 10.1002/bimj.201600202 | ||||||||
| Status: | Peer Reviewed | ||||||||
| Publication Status: | Published | ||||||||
| Access rights to Published version: | Open Access | ||||||||
| Funder: | Seventh Framework Programme (European Commission) (FP7), National Institute for Health Research (Great Britain) (NIHR) | ||||||||
| Grant number: | FP HEALTH 2013-602144 (FP7), Grant No. PB-PG-0706-10080 (NIHR) |
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