Back to Agenda
Clinical Safety Assessment: What’s a Statistician Got to Do with It?
Session Chair(s)
Mat Soukup, PhD
Deputy Director, Division of Biometrics VII, OB, OTS CDER
FDA, United States
Statistical attention to safety data is often times left to routine, basic calculations and tabulations. Absent statistical input, the data run the risk of being presented in ways that are unintuitive, uninformative, or in the worst case, deceptive. Speakers in this session will present examples where statisticians are collaborating with clinical colleagues and data scientists to more effectively analyze and clinically interpret safety data.
Learning Objective : Recognize the importance of statistical engagement in the assessment of clinical trial safety data; Apply appropriate statistical methods in the analysis of safety data; Identify the need to work collaboratively with clinicians and data scientists.
Speaker(s)
Improving Analyses and Displays for Clinical Trial Safety Data
Mary Nilsson, MS
Eli Lilly and Company, United States
Researcher, Safety Analytics Group
ASA/DIA Safety WG Presents: Finding Safety Signals During Clinical Development with R Shiny
Susan Mayo, MS
FDA, United States
Senior Mathematical Statistician, CDER Office of Biostatistics
FDA Perspective
Matthew Guerra, PhD
FDA, United States
Mathematical Statistician, OB, OTS, CDER
Have an account?