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|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.|
(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.