Writing and Implementing Statistical Analysis Plans (SAPs) - Domestic and International Guidance under ICH E9

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.

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.

• The Dance Relationship between the SAP and the Clinical Protocol
• Timing of SAP preparation: Advantages of starting early and staying on top
• Regulatory considerations, ICH E9, E6, and E3
• Sections of the SAP, necessary and optional
• List of tables, formatting the tables
• Using the template to complete your SAP
• Integrated Safety SAP
• Integrated Efficacy SAP

Learning Objective:

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.

• Clinical research managers
• Project managers
• Marketing personnel in drug or medical devices companies
• Scientists and R & D personnel involved in evaluating efficacy of a new drug or medical device
• Quality personnel involved in evaluating safety of a new drug or medical device
• Documentation
• Anyone involved in writing or implementing a SAP
• Anyone involved in decision-making for clinical phases of drug or medical device development
• Bio statisticians

Topic Background:

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.