Early phase clinical trials extension to guidelines for the content of statistical analysis plans.
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Date
2022-02-07ICR Author
Author
Homer, V
Yap, C
Bond, S
Holmes, J
Stocken, D
Walker, K
Robinson, EJ
Wheeler, G
Brown, S
Hinsley, S
Schipper, M
Weir, CJ
Rantell, K
Prior, T
Yu, L-M
Kirkpatrick, J
Bedding, A
Gamble, C
Gaunt, P
Type
Journal Article
Metadata
Show full item recordAbstract
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.
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Subject
Clinical Trials as Topic
Guidelines as Topic
Data Analysis
Research team
Clinical Trials & Statistics Unit
Language
eng
Date accepted
2022-01-10
License start date
2022-02-07
Citation
BMJ (Clinical research ed.), 2022, 376 pp. e068177 - ?
Publisher
BMJ PUBLISHING GROUP