Practical considerations with survival analysis in studies with biomarker evaluations and implications on Clinical diagnostic devices
*Sasikiran Goteti, Novartis Pharmaceuticals Corporation 

Keywords: biomarkers, companion diagnostics, adaptive designs

In the context of clinical trials with biomarker evaluations, several aspects have to be considered at the trial design stage. Depending on the prior information available on the prognostic and predictive value of the biomarker, study population, hypothesis testing strategy, study analysis timelines in line with the companion diagnostic device development need to be evaluated. In this presentation, design strategies including adaptive designs for studies with biomarker considerations and the impact on the development of companion diagnostics will be discussed.