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

Homer, V. et al. (2022) Early phase clinical trials extension to guidelines for the content of statistical analysis plans. British Medical Journal, 376, e068177. (doi: 10.1136/bmj-2021-068177) (PMID:35131744) (PMCID:PMC8819597)

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: Articles
• Keywords: Clinical Trials as Topic, Guidelines as Topic, Data Analysis
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Hinsley, Miss Samantha
• Authors: Homer, V., Yap, C., Bond, S., Holmes, J., Stocken, D., Walker, K., Robinson, E. J., Wheeler, G., Brown, S., Hinsley, S., Schipper, M., Weir, C. J., Rantell, K., Prior, T., Yu, L.-M., Kirkpatrick, J., Bedding, A., Gamble, C., and Gaunt, P.
• College/School: College of Medical Veterinary and Life Sciences > School of Cancer Sciences
• Journal Name: British Medical Journal
• Publisher: BMJ Publishing Group
• ISSN: 1759-2151
• ISSN (Online): 0959-8138
• Copyright Holders: Copyright © 2022 BMJ Publishing Group Ltd
• First Published: First published in British Medical Journal 376: e068177
• Publisher Policy: Reproduced under a Creative Commons License