Early phase clinical trials extension to guidelines for the content of statistical analysis plans.
Embargo End Date
ICR Authors
Authors
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
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
Document Type
Journal Article
Date
2022-02-07
Date Accepted
2022-01-10
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.
Citation
BMJ (Clinical research ed.), 2022, 376 pp. e068177 - ?
Source Title
Publisher
BMJ PUBLISHING GROUP
ISSN
0959-8138
eISSN
1756-1833
1756-1833
1756-1833
Collections
Research Team
Clinical Trials & Statistics Unit