Ren, S. and Oakley, J.E. (2014) Assurance calculations for planning clinical trials with time-to-event outcomes. Statistics in Medicine, 33 (1). 31 - 45. ISSN 0277-6715
Abstract
We consider the use of the assurance method in clinical trial planning. In the assurance method, which is an alternative to a power calculation, we calculate the probability of a clinical trial resulting in a successful outcome, via eliciting a prior probability distribution about the relevant treatment effect. This is typically a hybrid Bayesian-frequentist procedure, in that it is usually assumed that the trial data will be analysed using a frequentist hypothesis test, so that the prior distribution is only used to calculate the probability of observing the desired outcome in the frequentist test. We argue that assessing the probability of a successful clinical trial is a useful part of the trial planning process. We develop assurance methods to accommodate survival outcome measures, assuming both parametric and nonparametric models. We also develop prior elicitation procedures for each survival model so that the assurance calculations can be performed more easily and reliably. We have made free software available for implementing our methods.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2013 The Author(s). This is an Open Access article distributed under the terms of the Creative Commons Attribution Licence (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Health and Related Research (Sheffield) The University of Sheffield > Faculty of Science (Sheffield) > School of Mathematics and Statistics (Sheffield) |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 23 Jun 2014 14:48 |
Last Modified: | 16 Nov 2015 11:49 |
Published Version: | http://dx.doi.org/10.1002/sim.5916 |
Status: | Published |
Publisher: | Wiley |
Refereed: | Yes |
Identification Number: | 10.1002/sim.5916 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:79488 |