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Designing a series of decision-theoretic phase II trials in a small population
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Hee, Siew Wan and Stallard, Nigel (2012) Designing a series of decision-theoretic phase II trials in a small population. Statistics in Medicine, Vol.31 (No.30). pp. 4337-4351. doi:10.1002/sim.5573 ISSN 0277-6715.
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Official URL: http://dx.doi.org/10.1002/sim.5573
Abstract
This paper introduces a decision-theoretic design for a series of phase II trials. Instead of designing phase II trials individually, we proposed a development plan that consists of a series of phase II trials and one phase III trial such that the long-term expected utility on the whole is optimized. The phase II trials are conducted sequentially, and patients are recruited sequentially to each phase II trial. At each interim stage, a decision is made to continue recruiting patients to the current trial, to stop and recommend the treatment proceeds to a phase III trial, to stop and initiate a new phase II trial or to stop and cease the development plan. The methodology uses a hybrid approach in which it is assumed that the data from the final phase III trial will be analysed using a classical frequentist hypothesis test. The expected power of this test based on some specified prior distribution for the effect of the experimental treatment is then used in a utility function, which is used to obtain the optimal design for the whole series of trials. Copyright © 2012 John Wiley & Sons, Ltd.
Item Type: | Journal Article | ||||
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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 |
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Journal or Publication Title: | Statistics in Medicine | ||||
Publisher: | John Wiley & Sons Ltd. | ||||
ISSN: | 0277-6715 | ||||
Official Date: | 2012 | ||||
Dates: |
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Volume: | Vol.31 | ||||
Number: | No.30 | ||||
Page Range: | pp. 4337-4351 | ||||
DOI: | 10.1002/sim.5573 | ||||
Status: | Peer Reviewed | ||||
Publication Status: | Published | ||||
Access rights to Published version: | Restricted or Subscription Access |
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