New Designs for Phase III Clinical Trials. Richard Simon, D.Sc. Chief, Biometric Research Branch National Cancer Institute http://brb.nci.nih.gov. BRB Website http://brb.nci.nih.gov. Powerpoint presentations & reprints BRB-ArrayTools software
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Richard Simon, D.Sc.
Chief, Biometric Research Branch
National Cancer Institute
Sally Hunsberger, Yingdong Zhao, and Richard Simon
For =0.05, =0.20, hr=1.5, E=75 events are required
For =0.10, 55 events
Using phase II data, develop predictor of response to new drug
Patient Predicted Responsive
Patient Predicted Non-Responsive
Wenyu Jiang, Boris Freidlin & Richard Simon
JNCI 99:1036-43, 2007
Boris Freidlin and Richard Simon
Clinical Cancer Research 11:7872-8, 2005