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Statistical Considerations for Clinical Trials in Developing Antimicrobial Drugs
Outline
Statistical Considerations Section in Guidance Document
Similarity (“Equivalence”) Trials
DAIDP Points to Consider - 1992
Points to Consider: Delta
Points to Consider: Unaddressed Issues
Similarity (“Equivalence”) Trials: Proposals (1)
Similarity (“Equivalence”) Trials: Proposals (2)
Intent-to-Treat Principle
Intent to Treat Analyses
Per Protocol Analyses
Intent to Treat & Per Protocol Analyses
Accounting for Patients #11; in Study Population
Missing Data
Missing Data: Sensitivity Analysis
Proposals
Similarity Trial Sample Size: #11; Per Arm (80% Power)
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Last update: July 8, 2005
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