The Value Of RWD In Safety Signal Refinement

Presented by:

Irene Cosmatos, MS, Senior Research Specialist, Database Analytics Automation, UBC
Ruben M. Ayzin Rosoky, MD, PhD, MFPM, Senior Safety Physician, Pharmacovigilance, UBC

Population-based RWD are increasingly used by US and EU regulators to complement passive safety surveillance that is based on review of adverse event spontaneous reports. The latter approach is frequently undermined by incomplete, inconsistent and insufficient data.

RWD provides key elements, such as longitudinality, large populations addressed and exposure details, allowing to assess causal relationships and their magnitudes and identify confounders and susceptible subpopulations at high risk. RWD provides value to all phases of safety assessment of post-marketed drugs. The presentation focuses on a recommended analytic approach for safety scientists, epidemiologists, and other researchers for evaluating the causality of a signal identified from one or more data sources.