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How to Develop a Statistical Analysis Plan for Clinical Trials

A statistical analysis plan (SAP) is a defined outline of the planned statistical analyses for a clinical trial, including basic and advanced methods. An SAP is crucial, as it is one of the key regulatory confidential documents in the development of a clinical trial. It provides explicit guidance on statistical programming, as well as the presentation of results for a clinical trial. Depending on the organisation, statistical analysis plans might also be known as reporting and analysis plans or data analysis plans. Rudra Patel at Kolabtree explains how to develop a statistical analysis plan for clinical trials.