Planning Clinical Development in Catheter Related Bacteremia Ray Zhu, Ph.D.

10/19/99


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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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