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So Much Data, So Little Time: Hot Topics in Benefit-Risk Assessment
Session Chair(s)
Meredith Smith, PhD, MPA, FISPE
Senior Director, Implementation Science Pillar Lead
Evidera, Inc, United States
Both regulators and sponsors are increasingly using structured frameworks to assess the benefit-risk profile of medicinal products. Such frameworks can accommodate a variety of data sources and can be supplemented by an array of graphical presentations. As experience with using structured benefit-risk assessment (SBRA) frameworks in both the pre- and post-market context accrues, a number of important questions remain, including: 1) What has been learned by FDA and EMA in regard to using a structured benefit-risk assessment framework for new drug application assessments? 2) How are these regulatory authorities continuing to train and support their reviewers in conducting such assessments? 3) What are the challenges involved in incorporating real world data into structured benefit-risk assessment analyses? 4) What are good practices in terms of evaluating the impact of different types of uncertainty on the quality of the benefit-risk assessment decision?
Learning Objective : Describe the FDA’s and EMA’s experiences to date in implementing structured approaches to benefit-risk assessment, including the use of the Effects Tables and other tools; Discuss the key considerations in evaluating the impact of uncertainty on the quality of the benefit-risk assessment decision; Identify the challenges involved in incorporating real world evidence into a structured benefit-risk assessment.
Speaker(s)
FDA's Experience to Date Using the Structured Benefit-Risk Assessment Framework to Support Regulatory Decision-Making
Graham Thompson
FDA, United States
Operations Research Analyst, Decision Support and Analysis Team, OSP, CDER
Use of Real World Evidence in Personalized Benefit-Risk Assessment: Closing the Knowledge Gap
Tarek Hammad, MD, PhD, MS, MSc, FISPE
Takeda, United States
Vice President, Head of Medical Safety, Marketed Products & Plasma-Derived Thera
EMA Perspective
Douwe Postmus, PhD, MSc
University Medical Center Groningen & EMA, Netherlands
Assistant Professor & Seconded National Expert
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