Biostatistics Seminar speaker, Ilya Lipkovich, PhD, Advisory Services, QuintilesIMS, will present, “Methods of biomarker and subgroup identification for personalized medicine.”
This talk will provide a relatively high-level description of a broad class of statistical methods dealing with exploratory subgroup analysis, i.e., subgroup search/biomarker discovery methods that can be applied both in early and late-phase clinical trials. I will also talk briefly about applying these methods in the context of seamless Phase 2//3 studies.
Discussion of exploratory subgroup analysis methods begins with a review of common approaches to subgroup identification in the context of personalized medicine and then focuses on the SIDES method (Lipkovich et al., 2011) and its extensions SIDEScreen and Stochastic SIDEScreen (Lipkovich and Dmitrienko, 2014, Lipkovich et al, 2017). Case studies from both early and late clinical development programs will be used to illustrate the principles and statistical methods introduced in this talk.
An overview of QuintilesIMS Advisory analytics group will be provided