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


Homer, Victoria, Yap, Christina, Bond, Simon, Holmes, Jane, Stocken, Deborah, Walker, Katrina, Robinson, Emily J, Wheeler, Graham, Brown, Sarah, Hinsley, Samantha et al (show 9 more authors) (2022) Early phase clinical trials extension to guidelines for the content of statistical analysis plans. BMJ-BRITISH MEDICAL JOURNAL, 376. e068177-.

Access the full-text of this item by clicking on the Open Access link.

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 and Life Sciences
Faculty of Health and Life Sciences > Institute of Population Health
Depositing User: Symplectic Admin
Date Deposited: 19 Jan 2023 15:26
Last Modified: 19 Jan 2023 15:26
DOI: 10.1136/bmj-2021-068177
Open Access URL: https://doi.org/10.1136/bmj-2021-068177
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3167157
Dimensions
Altmetric
CORE (COnnecting REpositories)