Early phase clinical trials extension to guidelines for the content of statistical analysis plans


Homer, V, Yap, C, Bond, S, Holmes, J, Stocken, D, Walker, K, Robinson, EJ, Wheeler, G, Brown, S, Hinsley, S et al (show 9 more authors) (2022) Early phase clinical trials extension to guidelines for the content of statistical analysis plans BMJ, 376. e068177-. ISSN 0959-8146, 1756-1833

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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.

Item Type: Article
Uncontrolled Keywords: Clinical Trials as Topic, Guidelines as Topic, Data Analysis
Divisions: Faculty of Health & Life Sciences
Faculty of Health & Life Sciences > Inst. Population Health
Depositing User: Symplectic Admin
Date Deposited: 19 Jan 2023 15:26
Last Modified: 28 Feb 2026 23:38
DOI: 10.1136/bmj-2021-068177
Open Access URL: https://doi.org/10.1136/bmj-2021-068177
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URI: https://livrepository.liverpool.ac.uk/id/eprint/3167157
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