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

Victoria Homer; Christina Yap; Simon Bond; Jane Holmes; Deborah Stocken; Katrina Walker; Emily J Robinson; Graham Wheeler; Sarah Brown; Samantha Hinsley; Matthew Schipper; Christopher J Weir; Khadija Rantell; Thomas Prior; Ly-Mee Yu; John Kirkpatrick; Alun Bedding; Carrol Gamble; Piers Gaunt

doi:10.1136/bmj-2021-068177

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

Victoria Homer, Christina Yap, Simon Bond, Jane Holmes, Deborah Stocken, Katrina Walker, Emily J Robinson, Graham Wheeler, Sarah Brown, Samantha Hinsley, Matthew Schipper, Christopher J Weir, Khadija Rantell, Thomas Prior, Ly-Mee Yu, John Kirkpatrick, Alun Bedding, Carrol Gamble, Piers Gaunt

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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.

Original language	English
Article number	e068177
Number of pages	10
Journal	BMJ
Volume	376
DOIs	https://doi.org/10.1136/bmj-2021-068177
Publication status	Published - 7 Feb 2022

Keywords

Clinical Trials as Topic
Data Analysis
Guidelines as Topic

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HomerV2022EarlyFinal published version, 317 KBLicence: Creative Commons: Attribution-NonCommercial (CC BY-NC)

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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., & Gaunt, P. (2022). Early phase clinical trials extension to guidelines for the content of statistical analysis plans. BMJ, 376, Article e068177. https://doi.org/10.1136/bmj-2021-068177

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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",

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Homer, V, Yap, C, Bond, S, Holmes, J, Stocken, D, Walker, K, Robinson, EJ, Wheeler, G, Brown, S, Hinsley, S, Schipper, M, Weir, CJ, Rantell, K, Prior, T, Yu, L-M, Kirkpatrick, J, Bedding, A, Gamble, C & Gaunt, P 2022, 'Early phase clinical trials extension to guidelines for the content of statistical analysis plans', BMJ, vol. 376, e068177. https://doi.org/10.1136/bmj-2021-068177

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T1 - Early phase clinical trials extension to guidelines for the content of statistical analysis plans

AU - Homer, Victoria

AU - Yap, Christina

AU - Bond, Simon

AU - Holmes, Jane

AU - Stocken, Deborah

AU - Walker, Katrina

AU - Robinson, Emily J

AU - Wheeler, Graham

AU - Brown, Sarah

AU - Hinsley, Samantha

AU - Schipper, Matthew

AU - Weir, Christopher J

AU - Rantell, Khadija

AU - Prior, Thomas

AU - Yu, Ly-Mee

AU - Kirkpatrick, John

AU - Bedding, Alun

AU - Gamble, Carrol

AU - Gaunt, Piers

PY - 2022/2/7

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AB - 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.

KW - Clinical Trials as Topic

KW - Data Analysis

KW - Guidelines as Topic

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DO - 10.1136/bmj-2021-068177

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SN - 1756-1833

VL - 376

JO - BMJ

JF - BMJ

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

Abstract

Keywords

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