R. Clifton Bailey Statistics Seminar Series
How to Design the Best Biomarker-Guided Clinical Trial?
Anatasia Ivanova
Professor
Department of Biostatistics
University of North Carolina at Chapel Hill
Date: Friday, November 3, 2023
Time: 11:00 A.M. – 12:00 P.M. Eastern Time
Location: Johnson Center, Room 325 Meeting Room A
Abstract
In a clinical trial with a predefined subgroup, it is assumed that the biomarker positive subgroup has the same or higher treatment effect compared to its complement, the biomarker negative subgroup. In these trials the treatment effect is usually evaluated in the biomarker positive subgroup and in the whole population. Statistical testing of the treatment effect in the biomarker negative subgroup is usually not done since it requires a larger sample size. As a result, the new intervention can be shown effective in the overall population even though it is only effective in the biomarker positive group. What can we do to improve decision making in such trials?
About the Speaker
Anastasia Ivanova is a Professor of Biostatistics at the University of North Carolina at Chapel Hill. Anastasia’s research area is complex designs for clinical trials including adaptive designs, designs with re-randomization and enrichment, and dose-finding designs. Anastasia has published more than 170 peer refereed papers. She is an ASA Fellow and an Associate Editor of Statistics in Medicine.
Event Organizers
Nicholas Rios
David Kepplinger