Homer, V., Yap, C., Bond, S. et al. (16 more authors) (2022) Early phase clinical trials extension to guidelines for the content of statistical analysis plans. The BMJ, 376. e068177. ISSN 0959-8138
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.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is noncommercial. See: http://creativecommons.org/licenses/by-nc/4.0/. |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) |
Depositing User: | Symplectic Publications |
Date Deposited: | 28 Mar 2025 10:56 |
Last Modified: | 28 Mar 2025 10:56 |
Published Version: | https://www.bmj.com/content/376/bmj-2021-068177 |
Status: | Published |
Publisher: | BMJ |
Identification Number: | 10.1136/bmj-2021-068177 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:224955 |
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Filename: Early phase clinical trials extension to guidelines for the content.pdf
Licence: CC-BY-NC 4.0