Early phase clinical trials extension to guidelines for the content of statistical analysis plans. (7th February 2022)

• Record Type: Journal Article
• Authors: Homer, Victoria; Yap, Christina; Bond, Simon; Holmes, Jane; Stocken, Deborah; Walker, Katrina; Robinson, Emily J; Wheeler, Graham; Brown, Sarah; Hinsley, Samantha; Schipper, Matthew; Weir, Christopher J; Rantell, Khadija; Prior, Thomas; Yu, Ly-Mee; Kirkpatrick, John; Bedding, Alun; Gamble, Carrol; Gaunt, Piers
• Is Part Of: BMJ. Volume 376(2022)
• Publication Date: 2022-02-07
• Subjects: Medicine -- Periodicals; Medicine -- Periodicals; Medicine; Periodicals; 610
• DOI: 10.1136/bmj-2021-068177
• Languages: English
• ISSNs: 0007-1447

Abstract

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.