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JMP Innovation Theater: Adverse Events in Clinical Trials: When Doctors Require a Statistical Perspective
Session Chair(s)
Kelci Miclaus, PhD, MS
Senior Director
Veeva Systems, United States
Medical reviewers are more sophisticated when evaluating the adverse events associated with treatment than the ICH E3 document reflected 25 years ago. A more modern approach for doctors at regulatory agencies and sponsors is to rely on statistical concepts such as relative risk, incidence rates, time to event and Bayesian statistics to make a more informed decision on the safety of patients in clinical trials. Summarizations using tables and graphs will be shared to illustrate these concepts.
Speaker(s)
Panelist
Geoff Mann, PhD
JMP Statistical Discovery, United States
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