Julious, S.A. (2011) The ABC of non-inferiority margin setting from indirect comparisons. Pharmaceutical Statistics, 10 (5). pp. 448-453. ISSN 1539-1604
Abstract
In a non‐inferiority trial to assess a new investigative treatment, there may need to be consideration of an indirect comparison with placebo using the active control in the current trial. We can, therefore, use the fact that there is a common active control in the comparisons of the investigative treatment and placebo. In analysing a non‐inferiority trial, the ABC of: Assay sensitivity, Bias minimisation and Constancy assumption needs to be considered. It is highlighted how the ABC assumptions can potentially fail when there is placebo creep or a patient population shift. In this situation, the belief about the placebo response expressed in terms of a prior probability in Bayesian formulation could be used with the observed treatment effects to set the non‐inferiority limit.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2011 John Wiley & Sons, Ltd. |
Keywords: | clinical trials; indirect comparisons; non-inferiority; placebo creep; statistical methods; clinical trials |
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) > ScHARR - Sheffield Centre for Health and Related Research |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 18 Feb 2020 10:35 |
Last Modified: | 18 Feb 2020 10:35 |
Status: | Published |
Publisher: | Wiley |
Refereed: | Yes |
Identification Number: | 10.1002/pst.517 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:157284 |