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Wednesday, June 17 • 12:45pm - 1:15pm
#324 SL-IT: JMP Innovation Theater: Adverse Events in Clinical Trials: When Doctors Require a Statistical Perspective

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Component Type: Session

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.


Kelci Miclaus, PhD, MS


Geoff Mann, PhD

avatar for Geoff Mann

Geoff Mann

Advanced Analytics Manager, JMP Statistical Discovery, United States
Geoffrey Mann is Advanced Analytics Manager for the health and life sciences industry at JMP. In this role, he explores needs for visual and statistical discovery software in the clinical segment of the pharmaceutical and healthcare industries. After joining SAS in 2000, he helped... Read More →
avatar for Kelci Miclaus

Kelci Miclaus

Sr Manager, Advanced Analytics R&D, SAS Institute Inc., JMP Division
Dr. Kelci Miclaus is Advanced Analytics Sr. Manager for the JMP Life Sciences division at SAS Institute where she manages the R&D team and develops statistical features for JMP Genomics and JMP Clinical software. She joined SAS in 2006 and holds a PhD in Statistics from North Carolina... Read More →

Wednesday June 17, 2020 12:45pm - 1:15pm EDT
TBD Virtual Event Horsham, PA 19044