Design of Clinical Trials of Antibiotic Therapy for Acute Otitis Media

7/19/02


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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?

Author: Colin Marchant