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. 2022 Feb 7:376:e068177.
doi: 10.1136/bmj-2021-068177.

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

Victoria Homer  1 , Christina Yap  2 , Simon Bond  3 , Jane Holmes  4 , Deborah Stocken  5 , Katrina Walker  5 , Emily J Robinson  6 , Graham Wheeler  7 , Sarah Brown  5 , Samantha Hinsley  8 , Matthew Schipper  9 , Christopher J Weir  10 , Khadija Rantell  11 , Thomas Prior  12 , Ly-Mee Yu  13 , John Kirkpatrick  14 , Alun Bedding  14 , Carrol Gamble  15 , Piers Gaunt  16
Affiliations

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

Victoria Homer et al. BMJ. .

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.

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Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: support from the NIHR for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work. There is no additional data available.

Figures

Fig 1
Fig 1
Results of literature review (as of 22 October 2020) of existing guidance for content of statistical analysis plans (SAPs). *Other reasons of non-relevance include statistical and clinical trials methodology and literature reviews, statistical analysis plans for substudies of randomised controlled trials, and statistical analysis plans for substudies
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References

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