The webinar will focus on the biomarker-based designs of clinical trials.
We will review the recently proposed-designs, including adaptive designs, and discuss the main issues related to their application. Their ability to validate the biomarker and/or to establish the effect of an experimental therapy in patient populations defined by the presence or absence of the biomarker is analyzed.
The talk considers biomarkers that modify the prognosis of individual patients ("prognostic" biomarkers) and biomarkers that predict how individual patients will respond to specific treatments ("predictive" biomarkers, also called "effect modifiers").
All discussed methods and concepts will be illustrated by using real-life examples from oncology.
