A statistical analysis plan (SAP) is a document that describes how statistical methods will be used to analyze data from a clinical trial. The SAP is typically written before the start of the trial and is used to ensure that the data are analyzed in a consistent and unbiased manner. The FDA has developed a template for SAPs that can be used by sponsors of clinical trials.
The FDA’s SAP template includes sections on the following topics:
Study Objectives and Endpoints
The SAP should clearly state the objectives of the study and the endpoints that will be used to assess the effectiveness of the intervention. The endpoints should be defined in a way that is objective and measurable.
The SAP should also specify the statistical methods that will be used to analyze the data. These methods should be appropriate for the type of data that will be collected and the study objectives. The SAP should also include a discussion of the assumptions that are made in the statistical analysis.
Sample Size and Power Analysis
The SAP should include a sample size and power analysis to determine the number of participants that need to be enrolled in the study. The power analysis should be based on the effect size that the study is expected to detect.
The SAP should also include a discussion of the potential risks of bias in the study. These risks should be considered when designing the study and analyzing the data. The SAP should also include a plan for how to address any potential biases.
Data Management and Analysis
The SAP should describe how the data will be collected, managed, and analyzed. This section should include a discussion of the data cleaning and transformation procedures that will be used. The SAP should also include a description of the statistical software that will be used to analyze the data.
The SAP should include a plan for how the results of the study will be disseminated. This plan should include a discussion of the target audience for the results and the methods that will be used to disseminate the results.
Conclusion
The SAP is an important document that helps to ensure that the data from a clinical trial are analyzed in a consistent and unbiased manner. The FDA’s SAP template can be used by sponsors of clinical trials to develop a SAP that meets the FDA’s requirements.
By following the FDA’s SAP template, sponsors can help to ensure that the results of their clinical trials are accurate and reliable.
