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Comment & Response
May 8, 2018

Statistical Analysis Plans for Clinical Trials—Reply

Author Affiliations
  • 1Biostatistics Department, University of Liverpool, Liverpool, England
  • 2Edinburgh University, Edinburgh, Scotland
  • 3Luxembourg Institute of Health, Strassen, Luxembourg
JAMA. 2018;319(18):1938-1939. doi:10.1001/jama.2018.2585

In Reply We would like to clarify that “Guidelines for Content of Statistical Analysis Plans”1 provides guidance for the content of a separate document rather than within the protocol of a clinical trial as suggested by Dr Cesana. As stated in the article, we believe that the level of detail required for a SAP goes beyond that which can reasonably be included within a clinical trial protocol.