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Clinical Trials of Predictive Medicine New Challenges and Paradigms. Richard Simon, D.Sc. Chief, Biometric Research Branch National Cancer Institute http://brb.nci.nih.gov. Biometric Research Branch Website 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
http://brb.nci.nih.gov
How Can We Develop New Drugs in a Manner More Consistent With Modern Tumor Biology and Obtain Reliable Information About What Regimens Work for What Kind of Tumors?
Develop Predictor of Response to New Drug
Using phase II data, develop predictor of response to new drug
Patient Predicted Responsive
Patient Predicted Non-Responsive
Off Study
New Drug
Control
Response to New Rx
Predicted Responsive
To New Rx
Predicted Non-responsive to New Rx
New RX
Control
New RX
Control
Biomarker Stratified DesignWenyu Jiang, Boris Freidlin, Richard Simon