Table of Contents
Planning Clinical Development in Catheter Related Bacteremia Ray Zhu, Ph.D.
Difficulties in Trial Design
Decision on Effectiveness: issues
Risk of Passing an Inferior Trt (? = -20%)
Risk of Approval for Inferiors: chance (%) of passing non-inferiority criteria for a drug having inferior response
Risk Analyses: Summary
Balance Risk, Evidence and Feasibility Recommendation
Summary of Critical Issues
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