Transparency in the conduct and reporting of clinical trials is supported by the guidance produced on the content of clinical trial protocols and reporting standards for clinical trials. While the principle features of the statistical analysis are required within this guidance it is generally accepted that a separate Statistical Analysis Plan is also developed as the level of detail appropriate for a SAP is excessive for a protocol. However, there is no detailed guidance on the content of a SAP and consequently, there is marked variation in practice.

The need to develop guidance on SAPs was raised during discussion by statisticians attending a UK Clinical Research Collaboration (UKCRC) Registered CTU Statisticians’ network meeting in November 2012, a group comprised of 46 senior statisticians, each representing their CTU within the network. In addition, the need for detailed SAP guidance was also identified independently by an international stakeholders group on outcome reporting bias due to the important role of SAPs in reducing biases such as selective reporting of outcomes and analyses.

Our aim was to create specific guidance for the authors of SAPs to:

a) improve efficiency and reduce variation

b)support journal editors and reviewers in peer review processes involving statistical analysis plans

c) reduce selective reporting of analyses.

 

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