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Decision-theoretic designs for small trials and pilot studies : a review
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Hee, Siew Wan, Hamborg, Thomas, Day, Simon, Madan, Jason, Miller, F., Posch, Martin, Zohar, Sarah and Stallard, Nigel (2016) Decision-theoretic designs for small trials and pilot studies : a review. Statistical methods in medical research, 25 (3). pp. 1022-1038. doi:10.1177/0962280215588245 ISSN 0962-2802.
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Official URL: http://dx.doi.org/10.1177/0962280215588245
Abstract
Pilot studies and other small clinical trials are often conducted but serve a variety of purposes and there is little consensus on their design. One paradigm that has been suggested for the design of such studies is Bayesian decision theory. In this article, we review the literature with the aim of summarizing current methodological developments in this area. We find that decision-theoretic methods have been applied to the design of small clinical trials in a number of areas. We divide our discussion of published methods into those for trials conducted in a single stage, those for multi-stage trials in which decisions are made through the course of the trial at a number of interim analyses, and those that attempt to design a series of clinical trials or a drug development programme. In all three cases, a number of methods have been proposed, depending on the decision maker’s perspective being considered and the details of utility functions that are used to construct the optimal design.
Item Type: | Journal Article | ||||||
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Subjects: | R Medicine > RA Public aspects of medicine | ||||||
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, Bayesian statistical decision theory | ||||||
Journal or Publication Title: | Statistical methods in medical research | ||||||
Publisher: | Sage Publications Ltd. | ||||||
ISSN: | 0962-2802 | ||||||
Official Date: | June 2016 | ||||||
Dates: |
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Volume: | 25 | ||||||
Number: | 3 | ||||||
Number of Pages: | 17 | ||||||
Page Range: | pp. 1022-1038 | ||||||
DOI: | 10.1177/0962280215588245 | ||||||
Status: | Peer Reviewed | ||||||
Publication Status: | Published | ||||||
Access rights to Published version: | Restricted or Subscription Access | ||||||
Date of first compliant deposit: | 13 April 2016 | ||||||
Date of first compliant Open Access: | 13 April 2016 | ||||||
Funder: | Seventh Framework Programme (European Commission) (FP7) | ||||||
Grant number: | FP HEALTH 2013 – 602144 (FP7) |
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