Integration of Diagnostic Markers into the Development Process of Targeted Agents.pptVIP

Integration of Diagnostic Markers into the Development Process of Targeted Agents Richard Simon, D.Sc. Chief, Biometric Research Branch National Cancer Institute BRB Website Powerpoint presentations Reprints BRB-ArrayTools software Web based Sample Size Planning Programs Optimal 2-stage phase II designs Phase III designs using predictive biomarkers Phase II/III designs Diagnostic Markers Predictive biomarkers Measured before treatment to identify who is likely or unlikely to benefit from a particular treatment Prognostic biomarkers Measured before treatment to indicate long-term outcome for