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TRAFIC: statistical design and analysis plan for a pragmatic early phase 1/2 Bayesian adaptive dose escalation trial in rheumatoid arthritis

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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Publisher copy:
10.1186/s13063-021-05384-5

Authors

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Role:
Author
ORCID:
0000-0003-3426-3717
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Role:
Author
ORCID:
0000-0002-6715-2514
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Institution:
University of Oxford
Role:
Author
ORCID:
0000-0001-6924-6402
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Role:
Author
ORCID:
0000-0002-5539-388X
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Role:
Author
ORCID:
0000-0002-6462-4280


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Funder identifier:
10.13039/501100000265
Grant:
MR/L005123/1


Publisher:
BioMed Central
Journal:
Trials More from this journal
Volume:
22
Issue:
1
Pages:
433-433
Article number:
433
Publication date:
2021-07-06
DOI:
EISSN:
1745-6215
ISSN:
1745-6215


Language:
English
Keywords:
Pubs id:
1186591
Local pid:
pubs:1186591
Source identifiers:
W3181942203
Deposit date:
2026-03-25
ARK identifier:
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