Using Genomics in Clinical Trial Design. Richard Simon, D.Sc. Chief, Biometric Research Branch National Cancer Institute http://linus.nci.nih.gov. BRB Website http://linus.nci.nih.gov/brb. Powerpoint presentations and audio files Reprints & Technical Reports BRB-ArrayTools software
Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.
Richard Simon, D.Sc.
Chief, Biometric Research Branch
National Cancer Institute
Using phase II data, develop predictor of response to new drug
Patient Predicted Responsive
Patient Predicted Non-Responsive
We don’t think that this drug will help you because your tumor is test negative. But we need to show the FDA that a drug we don’t think will help test negative patients actually doesn’t
Wenyu Jiang, Boris Freidlin & Richard Simon
JNCI 99:1036-43, 2007
Boris Freidlin and Richard Simon
Clinical Cancer Research 11:7872-8, 2005