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.
Gamble C, Lewis S, Senn S. Statistical Analysis Plans for Clinical Trials—Reply. JAMA. 2018;319(18):1938–1939. doi:10.1001/jama.2018.2585
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