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Quantitative Benefit-risk in the Current Regulatory Environment and the Implications for Clinical Statisticians
Session Chair(s)
Susan Mayo, MS
Senior Mathematical Statistician, CDER Office of Biostatistics
FDA, United States
Benefit-risk in clinical development is increasingly important to statisticians, as interest from regulators in more formal methods increases. We will describe decision science and statistical approaches, and what more statisticians can do in this area.
Learning Objective : Describe current international regulatory guidance for benefit-risk as it relates to clinical statisticians; Explain examples of benefit-risk methods from several perspectives; Discuss the need for more mature benefit-risk quantification methodologies. .
Speaker(s)
An Example of Benefit-risk Analysis Applying the BRAT Framework
Conny Berlin, MS
Novartis Pharma AG, Switzerland
IMI PREFER Project Leader & Global Head, Quantitative Safety and Epidemiology
A Regulator's View of Quantitative Benefit-risk Analysis
Jonathan D. Norton, PhD
FDA, United States
Mathematical Statistician, Division of Biometrics V, OB, OTS, CDER
Benefit-risk Evaluation: Concepts and Methods
Scott Evans, PhD, MS
George Washington University Milken Institute of Public Health, United States
Professor and Founding Chair, Department of Biostatistics and Bioinformatics
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