The Role of RWD After Safety Signals are Identified: Analytic Approaches to Refining a Safety Signal

The Role of RWD After Safety Signals are Identified: Analytic Approaches to Refining a Safety Signal

I was pleased to recently attend and present at the SCOPE Conference in Orlando, FL. The following summarizes the presentation (coauthored by my colleague, Ruben M. Ayzin Rosoky, MD, PhD, MFPM, Senior Safety Physician, UBC Pharmacovigilance):

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. RWD provides key elements to assess causal relationships and their magnitudes as well as identify confounders and susceptible subpopulations at high risk, such as longitudinality, population-based, and exposure details. RWD provides values to all phases of safety assessment of post-marketed drugs (i.e., signal detection, signal refinement, signal evaluation). Our presentation focuses on a recommended analytic approach for safety scientists, epidemiologists, and other researchers to start evaluating causality of a signal that was identified through one or more data sources (adverse event database, literature, RWD)…. i.e., Signal refinement phase. Our analyses are based on UBC’s simulated database, which represents patterns of health care utilization and diagnoses of the US population based on actual US administrative claims databases. Strength and limitations of the method are discussed.

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