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Predictive Biomarkers in Phase II/III Clinical Trials
Biomarker Targeted Randomized Design
Biomarker Stratified Randomized Design
Binary Endpoint
Time-to-Event Endpoint
Optimal Two-Stage Designs For Phase II Clinical Trials
Integrated Phase II/III Study
Sample Size Planning for Developing Classifiers Using High Dimensional Data
Design, Monitoring and Analysis of Bayesian Basket Discovery Trials
Bayesian Phase II Single Arm Clinical Trials (Binary Outcomes)
Bayesian Phase II Single Arm Clinical Trials (Time to Event Outcomes)
Online Sample Size Calculation
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Predictive Biomarkers in Phase II/III Clinical Trials
Biomarker Stratified Randomized Design
Stratified design randomizes both marker positive and negative patients.
Richard Simon, Clinical Cancer Research 14:5984-93, 2008.
Richard Simon, Expert Opinion in Medical Diagnostics, 2:721-29, 2008.
Richard Simon, Developing Molecular Diagnostics for Cancer (Winther & Jorgensen eds).
Stratified Design with Prospective Analysis Plan and Binary Endpoint
Stratified Design with Prospective Analysis Plan and Time-to-Event Endpoint
