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Journal article

Non-adherence in non-inferiority trials: pitfalls and recommendations

Abstract:
Non-adherence in non-inferiority trials can affect treatment effect estimates and often increases the chance of claiming non-inferiority under the standard intention-to-treat analysis. This article discusses the implications of different patterns of non-adherence in non-inferiority trials and offers practical recommendations for trial design, alternative analysis strategies, and outcome reporting to reduce bias in treatment estimates and improve transparency in reporting.
Publication status:
Published
Peer review status:
Peer reviewed

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Publisher copy:
10.1136/bmj.m2215

Authors


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Role:
Author
ORCID:
0000-0002-0216-9550
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Institution:
University of Oxford
Division:
MSD
Department:
NDM
Sub department:
Tropical Medicine
Role:
Author
ORCID:
0000-0002-1897-1978


Publisher:
BMJ Publishing Group
Journal:
BMJ More from this journal
Volume:
370
Article number:
m2215
Publication date:
2020-07-01
Acceptance date:
2020-05-07
DOI:
EISSN:
1756-1833
ISSN:
0959-8138
Pmid:
32611541


Language:
English
Keywords:
Pubs id:
1116730
Local pid:
pubs:1116730
Deposit date:
2020-08-13

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