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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.

Original publication

DOI

10.1136/bmj-2021-068177

Type

Journal article

Journal

The BMJ

Publication Date

07/02/2022

Volume

376