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Session 7: Insights on Benefit-Risk Assessment
Session Chair(s)
Mengchun Li, MD, MPA
Senior Director, Clinical Research, Infectious Disease
Merck & Co., Inc., United States
Jeremy Jokinen, PhD, MS
Vice President and Head, Safety Evidence and Sciences
Bristol-Myers Squibb Company, United States
The CIOMS WG XII Benefit-Risk report was released, outlining the benefit-risk (BR) landscape and promoting the use of a structured BR framework (SBRF) from the beginning and continuously updated and applied throughout the product lifecycle, including key decision-making steps. This will enable a shift from evaluating BR from unstructured ways towards a more structured, transparent multi-stakeholder approach. Also, it advocated for including patient-centric endpoints that capture both benefit and risk in clinical trial designs. Members from CIOMS WG XII will provide an overview of this document, and panelists will be invited to share insights from different perspectives.
Learning Objective : - Describe the key recommendations from the CIOMS WG XII Benefit-Risk report
- Recognize the gaps between the current practice and the recommendations from the CIOMS WG XII Benefit-Risk report
- Prepare to implement relevant components from the CIOMS WG XII Benefit-Risk report in day job
- Deploy a multi-functional team for structured benefit risk assessment
- Initiate internal conversations to facilitate incorporating patient input to inform SBRF
Speaker(s)
CIOMS Working Group (WG) XII Report: Overview and Chapter II-Structured BR Approach/Framework
Hong Yang, PhD
FDA, United States
Biologist, OBPV, CBER
CIOMS Working Group (WG) XII Report: Chapter III-BR Methodology Considerations
Richard Forshee, PhD
FDA, United States
Deputy Director, OBPV CBER
Speakers
Susan Colilla, PhD, MPH
Teva Pharmaceuticals, United States
Epidemiology Leader
Panelist
Brian Edwards, DrMed
International Society of Pharmacovigilance, United Kingdom
Vice President