@article{a88280539f494b55868516e5644a0970,
title = "Early phase clinical trials extension to the guidelines for the content of statistical analysis plans",
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.",
author = "Victoria Homer and Christina Yap and Simon Bond and Jane Holmes and Deborah Stocken and Katrina Walker and Robinson, {Emily J.} and Graham Wheeler and Sarah Brown and Samantha Hinsley and Matthew Schipper and Weir, {Christopher J} and Khadija Rantell and Thomas Prior and Ly-Mee Yu and John Kirkpatrick and Alun Bedding and Carrol Gamble and Piers Gaunt",
note = "Funding Information: Centre (funded by the NIHR) and Advanced Therapy Treatment Centre (funded by Innovate UK). Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.",
year = "2022",
month = feb,
day = "7",
doi = "10.1136/bmj-2021-068177",
language = "English",
volume = "376",
journal = "British Medical Journal",
issn = "0959-8138",
publisher = "BMJ Publishing Group",
}