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Activity Number: 614 - Reasonable Possibility - Statistical Science of Safety Monitoring
Type: Topic Contributed
Date/Time: Thursday, August 2, 2018 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #330103 Presentation
Title: Practical Considerations in Planning and Implementing Aggregate Safety Monitoring
Author(s): Bill Wang*
Companies: Merck
Keywords: Aggregate Safety Monitoring; Reasonable Possibility; Safety Estimands

Safety monitoring is a continuous process taking place throughout the life cycle of drug development. The process is holistic, collective, and iterative; it requires cross-disciplinary collaborations to achieve its noble mission of protecting patient safety and promoting public health.

This presentation will propose a general process and discuss practical considerations in planning and implementing aggregate safety monitoring. The key driver for this process is to detect potential safety signal and to establish the "reasonable possibility" of its relationship with treatment intervention. We will discuss practical consideration in (1) defining safety estimand (2) designing safety data collection (3) planning and performing ongoing safety monitoring, and (4) preparing for safety related regulatory filings and communication.

This presentation is on behalf of the ASA safety working group.

Authors who are presenting talks have a * after their name.

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