Journal article
Handling an uncertain control group event risk in non-inferiority trials: non-inferiority frontiers and the power-stabilising transformation
- Abstract:
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Background
Non-inferiority trials are increasingly used to evaluate new treatments that are expected to have secondary advantages over standard of care, but similar efficacy on the primary outcome. When designing a non-inferiority trial with a binary primary outcome, the choice of effect measure for the non-inferiority margin (e.g. risk ratio or risk difference) has an important effect on sample size calculations; furthermore, if the control event risk observed is m...
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- Publication status:
- Published
- Peer review status:
- Peer reviewed
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(Preview, Version of record, 1.0MB, Terms of use)
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- Publisher copy:
- 10.1186/s13063-020-4070-4
Authors
- Publisher:
- BioMed Central
- Journal:
- Trials More from this journal
- Volume:
- 21
- Article number:
- 145
- Publication date:
- 2020-02-06
- Acceptance date:
- 2020-01-13
- DOI:
- EISSN:
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1745-6215
- Language:
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English
- Keywords:
- Pubs id:
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pubs:1082191
- UUID:
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uuid:9a5b059c-02b4-47e2-a977-45e3998f2996
- Local pid:
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pubs:1082191
- Source identifiers:
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1082191
- Deposit date:
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2020-01-13
Terms of use
- Copyright holder:
- Quartagno, M et al.
- Copyright date:
- 2020
- Rights statement:
- © The Author(s) 2020. Open Access. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
- Licence:
- CC Attribution (CC BY)
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