Guidelines for the Content of Statistical Analysis Plans in Clinical Trials.

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Abstract

While guidance on statistical principles for clinical trials exists, there is an absence of guidance covering the required content of statistical analysis plans (SAPs) to support transparency and reproducibility.

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Journal

Journal ID (iso-abbrev): JAMA

Title: JAMA

Publisher: American Medical Association (AMA)

ISSN (Electronic): 1538-3598

ISSN (Print): 0098-7484

Publication date (Electronic): December 19 2017

Volume: 318

Issue: 23

Affiliations

[1 ] Biostatistics Department, University of Liverpool, Liverpool, England.

[2 ] Clinical Trials Research Centre, University of Liverpool, Liverpool, England.

[3 ] Newcastle University, Newcastle, England.

[4 ] Currently with Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, England.

[5 ] Edinburgh University, Edinburgh, Scotland.

[6 ] University of Oxford, Oxford, England.

[7 ] UCL Comprehensive Clinical Trials Unit, London, England.

[8 ] Centre for Statistics in Medicine, University of Oxford, Oxford, England.

[9 ] University of Nottingham, Nottingham, England.

[10 ] Janssen Research & Development LLC, Raritan, New Jersey.

[11 ] Johnson & Johnson, Titusville, New Jersey.

[12 ] Luxembourg Institute of Health, Strassen, Luxembourg.

[13 ] Clinical Trials Consulting & Training Limited, Buckingham, England.

[14 ] Medicines and Healthcare Products Regulatory Agency, London, England.

[15 ] , London, England.

Article

Publisher Item ID: 2666509

DOI: 10.1001/jama.2017.18556

PubMed ID: 29260229

SO-VID: b4b4c0c5-40bc-49ac-9680-6e20e80d643e

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