@article{dc230ab6395f4550a88a1ddd22666e91,
title = "Early phase clinical trials extension to 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. ",
keywords = "Clinical Trials as Topic, Data Analysis, Guidelines as Topic",
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",
year = "2022",
month = feb,
day = "7",
doi = "10.1136/bmj-2021-068177",
language = "English",
volume = "376",
journal = "BMJ",
issn = "1756-1833",
publisher = "BMJ Publishing Group",
}