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Early phase clinical trials extension to guidelines for the content of statistical analysis plans

Abstract:
This paper reports guidelines for the content of statistical analysis plans for early phase clinical trials, ensuring specification of the minimum reporting analysis requirements, by detailing extensions (11 new items) and modifications (25 items) to existing guidance after a review by various stakeholders
Publication status:
Published
Peer review status:
Peer reviewed

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Files:
Publisher copy:
10.1136/bmj-2021-068177
Publication website:
http://eprints.gla.ac.uk/266179/1/266179.pdf

Authors

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Role:
Author
ORCID:
0000-0003-3639-7874
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Role:
Author
ORCID:
0000-0002-6715-2514
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Role:
Author
ORCID:
0000-0003-2528-1040
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Institution:
University of Oxford
Role:
Author
ORCID:
0000-0001-7123-0004
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Role:
Author
ORCID:
0000-0001-8031-1738


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Funder identifier:
10.13039/501100000272


Publisher:
BMJ
Journal:
The BMJ More from this journal
Volume:
376
Pages:
e068177-e068177
Publication date:
2022-02-07
Acceptance date:
2022-01-10
DOI:
ISSN:
1756-1833


Language:
English
Keywords:
Pubs id:
1239254
Local pid:
pubs:1239254
Source identifiers:
W4210880568
Deposit date:
2026-04-09
ARK identifier:
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