Statistics and Data Science Seminar
Xin Huang
AbbVie, Inc
Paths to precision medicine: Exploratory Subgroup Analysis in Clinical Trials
Abstract: Mechanistic relationships between the clinical outcome (efficacy or safety
endpoints) versus putative biomarkers, clinical baseline and related
predictors are usually unknown, and must be deduced empirically from
experimental data. Such relationships enable the implementation of a
personalized medicine strategy in clinical trials to help stratify patients
in terms of disease progression, clinical response, treatment differentiation,
etc. These relationships are often requires complex modelling to develop the
prognostic and predictive signatures. For the purpose of easier interpretation
and implementation in the clinical practice, defining a multivariate biomarker
signature in terms of thresholds on the biomarker combinations is preferable.
In this presentation, we propose some methods for developing such signatures
in the context of continuous, binary and time-to-event endpoints. Results from
simulations and case-study illustration will also be provided.
Wednesday April 15, 2015 at 4:00 PM in SEO 636