Slide 1A New Paradigm for the Utilization of Genomic Classifiers for Patient Selection in the Critical Path of Medical Product Development Richard Simon, D.Sc. Chief, Biometric…

Using Genomics in the Design of Phase III Clinical Trials Richard Simon, D.Sc. Chief, Biometric Research Branch National Cancer Institute http://linus.nci.nih.gov Nothing…

Slide 1 Demonstrating Clinical Effectiveness of a Follow-On Companion Diagnostic Test When a New Clinical Trial is Unfeasible Abha Sharma, Roche Molecular Systems, May 2015…

Overall and subgroup analysis If the OVERALL results show highly significant evidence of a worthwhile effect of treatment, but a few subgroups of the overview unexpectedly…

Targeted (Enrichment) Design Prospective Co-Development of Drugs and Companion Diagnostics Develop a completely specified genomic classifier of the patients likely to benefit…