A Statistical Analysis Plan (SAP) is a document that outlines the statistical methods that will be used to analyze the data from a clinical trial. It is a detailed plan that specifies the hypotheses to be tested, the statistical tests to be performed, the sample size and power calculations, and the data handling and missing data procedures. The SAP is usually developed before the trial begins and is used as a guide for the conduct and analysis of the trial.
The main components of a Statistical Analysis Plan include:
Objectives: The primary and secondary objectives of the trial, along with the corresponding hypotheses to be tested.
Study design: A description of the trial design, including the treatment arms, randomization scheme, and the primary and secondary endpoints.
Sample size: A description of the sample size calculation and the justification for the chosen sample size.
Statistical methods: A detailed description of the statistical methods that will be used to analyze the data, including the specific tests or models to be used and the assumptions underlying them.
Data handling: A description of the data handling and missing data procedures, including any imputation methods that will be used.
Quality control: A description of the quality control procedures that will be used to ensure the accuracy and integrity of the data.
Data visualization: A description of the data visualizations that will be used to present the results, such as tables and figures.
Statistical significance: The level of statistical significance that will be used to determine whether the results are statistically significant.
Interim analysis: A description of any interim analyses that will be conducted, including the stopping rules and the methodologies used.
The Statistical Analysis Plan is an important document, as it ensures that the data will be analyzed in a consistent and scientifically rigorous manner. It helps to ensure that the results of the trial will be unbiased and will provide clear and accurate conclusions. Additionally, SAP is also reviewed and approved by regulatory authorities and ethics committee to ensure that it is adequate and appropriate for the trial.