Table of Contents
Design of Clinical Trials of Antibiotic Therapy for Acute Otitis Media
PPT Slide
The Pollyanna Phenomenon Measuring the Efficacy of Anti-bacterial Drugs in Acute Otitis Media
Sample Sizes Required to Detect Differences Between Antibacterial Drugs for Acute Otitis Media (AOM): Comparison of Bacteriologic Versus Clinical Outcomes in a Trial of 2 Drugs With Varying Bacteriologic Efficacy (Half the patients would be in each arm of a study)
Clinical Impact of Drug Efficacy
Clinical Impact of Drug Efficacy
Design Issues
Four Trial Designs
Parameters Used in Sample Size Calculations
Sample Sizes and # of Tympanocenteses (Taps) Various Study Designs Good Drug (90%) vs. Placebo (30%)
Sample Sizes and # of Tympanocenteses (Taps) Various Study Designs Good Drug (90%) vs. Poor Drug (50%)
Sample Sizes and # of Tympanocenteses (Taps) Various Study Designs Good Drug (90%) vs. Fair Drug (70%)
Sample Size for Measuring Efficacy of Antibiotics in Acute Otitis Media
Recommended Guidance for Industry Sample Size
Outcomes for Measuring the Efficacy of Antibiotic Therapy in Acute Otitis Media
Outcomes in Clinical Trials of Antibiotic Therapy in Acute Otitis Media
Recommended Guidance for Industry Trial Design - Tympanocentesis
Recommended Guidance for Industry Population Selection/Enrichment
Recommended Guidance for Industry Diagnostic Criteria
Ethical Issues
Do the benefits outweigh the risks?
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