Enhancing the QUAlity and Transparency Of health Research

Search for reporting guidelines

Use your browser's Back button to return to your search results

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

Reporting guideline provided for?
(i.e. exactly what the authors state in the paper)
Reporting of early phase (phase I and non-randomised phase II) clinical trial statistical analysis plans (SAPs).
Full bibliographic reference 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 LM, Kirkpatrick J, Bedding A, Gamble C, Gaunt P. Early phase clinical trials extension to guidelines for the content of statistical analysis plans. BMJ. 2022;376:e068177.
Language English
PubMed ID 35131744
Relevant URLs
(full-text if available)
Read the full-text of this reporting guideline for early phase clinical trial statistical analysis plans.
Relevant more generic / specialised reporting guidelines
(i.e. main generic guideline or extension to a generic guideline)
Clinical Trial Statistical Analysis Plans: Gamble C, Krishan A, Stocken D, Lewis S, Juszczak E, Doré C, Williamson PR, Altman DG, Montgomery A, Lim P, Berlin J, Senn S, Day S, Barbachano Y, Loder E. Guidelines for the Content of Statistical Analysis Plans in Clinical Trials. JAMA. 2017;318(23):2337-2343. PMID: 29260229
Study design Clinical trials, Experimental studies
Applies to the whole report or to individual sections of the report? Statistical analysis plan-whole report
Record last updated on February 14, 2022


Some reporting guidelines are also available in languages other than English. Find out more in our Translations section.

About the Library

For information about Library scope and content, identification of reporting guidelines and inclusion/exclusion criteria please visit About the Library.

Visit our Help page for information about searching for reporting guidelines and for general information about using our website.