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.