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Session 13: Innovations in Safety Signal Detection and Causality Assessment: From Knowledge Graphs to Best Practices
Session Chair(s)
James Buchanan, PHARMD
President, Covilance LLC, United States
This session will cover several topics pertaining to the identification and evaluation of safety signals. One presentation will discuss a multimodal data product approach using a knowledge graph (KG) to enhance signal detection. FDA has previously released their FDA Medical Queries (FMQ) concept. Now PhUSE has published a best practices document for the use of adverse event term groupings that will be reviewed. Having then identified a safety signal, an evaluation is conducted to seek evidence supporting a causal relationship. The final presentation will review various methodologies for conducting a causality assessment.
Learning Objective : - Describe how a Knowledge Graph integrates diverse structured and unstructured data sources for signal detection and its role in developing machine learning algorithms
- Recognize the PhUSE recommendations for the use of AE term groupings in signal detection
- Discuss the various approaches to considering evidence in support of a causal relationship between the drug and an adverse event
Speaker(s)
Peg Fletcher, MD, PHD
President, MedAssessment, Inc., United States
PHUSE White Paper: Use of Adverse Event Groupings in Clinical Trial Safety Assessments
Balmeet Gurm, MD
Executive Director, Therapeutic Area Lead Cardiovascular and EBs, Patient Safety, Bristol Myers Squibb, United States
Mutlimodal Safety Data products to enhance Signal Management and Detection
Salman Afsar, MD, MHA
Senior Director and Signal Management Team Chair, Bristol Myers Squibb, United States
Aspects to Consider in Causality Assessment of Safety Signals: Broadening the Thought Process