Abstract
Methods The project included: identification of existing SAP guidance; identifying and reviewing published SAPs; a survey of current practice within UKCRC registered Clinical Trial Units (rCTU) and a Delphi survey to establish consensus on SAP content. The Delphi survey included rCTU statisticians, CONSORT and SPIRIT guideline authors, experienced statisticians in the pharmaceutical industry, journal editors and regulators culminating in a face-to-face consensus meeting attended by experts from each demographic. These components informed the development of guidance for SAPs which subsequently underwent critical review by rCTU statisticians and experts from the consensus meeting, followed by piloting of the guidance document.
Highlights
ICH E9 guidelines recommend that a detailed SAP is prepared before breaking the trial blind
The Delphi survey included registered Clinical Trial Units (rCTU) statisticians, CONSORT and SPIRIT guideline authors, experienced statisticians in the pharmaceutical industry, journal editors and regulators culminating in a face-to-face consensus meeting attended by experts from each demographic
These components informed the development of guidance for SAPs which subsequently underwent critical review by rCTU statisticians and experts from the consensus meeting, followed by piloting of the guidance document
Summary
Development of guidance for statistical analysis plans (SAPs) for clinical trials. Ashma Krishan1*, Deborah Stocken, Steff Lewis, Ed Juszczak, Caroline Dore, Paula Williamson, Doug Altman, Alan Montgomery, Mike Clarke, Carrol Gamble. From 3rd International Clinical Trials Methodology Conference Glasgow, UK. From 3rd International Clinical Trials Methodology Conference Glasgow, UK. 16-17 November 2015
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