This training on clinical trial Statistical Analysis Plans (SAP) will review writing, timing and specific content of the SAP in the context of FDA guidance based on ICH E9 with references to ICH E3 and E6. We will work through a sample template and discuss how to approach each section for maximum clarity and ease of interpretation at the end of a study.
In this session, we will discuss commonly included sections of the SAP in the context of FDA guidance based on ICH E9 (Statistical Principles for Clinical Trials) with references to ICH E3 (Structure and Content of Clinical Study Reports) and E6 (Good Clinical Practices). References to complete and reliable SAP templates will be provided.
Why should you attend?
The statistical analysis plan (SAP) is a key component of a clinical trial. It is a prospective plan of statistical methods not detailed in the Protocol. While the protocol is primarily concerned with design considerations, such as study endpoints, type of control, and treatment groups for comparison, the SAP details the statistical model, analysis populations, and other quantitative analytical aspects of the study.
At the end of the webinar, participants will understand the role of the SAP in a clinical study and be able to use one of the many available templates to construct a complete and concise SAP for their next clinical protocol. Participants who do not need to create these documents will be better able to evaluate a sponsor's SAP for regulatory compliance.
Who will benefit?
The primary purpose of a statistical analysis plan (SAP) is to minimize bias. It should be prepared prior to unblinding the clinical study and should clearly state the proposed methods of dealing with missing data, early withdrawals, and protocol violations, and the way in which anticipated analysis problems specific to the study will be treated. It should also include a sample layout for the data summary tables to be produced.
Dr. Rita Hanover has concurrently held consulting positions for such companies as Pherin Pharmaceuticals, Utah Cancer Specialists, Montgomery-Watson Environmental Engineering, and Planned Parenthood Federation of America. She earned a Regulatory Affairs Certification (RAC) in 2006 through RAPS, and is also a member of the Society of Clinical Research Associates (SOCRA), and the American Statistical Association (AMSTAT).
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