Table of Contents
Selection of Delta to Determine Efficacy in Noninferiority Trials of Antibacterial Drugs
PhRMA’s Antimicrobial Working Group
Antimicrobial Working Group
Outline of Today’s Remarks
PhRMA’s Key Messages
Clinical Trials with Anti-infective Drugs: Unique Considerations
FDA’s Approach Throughout the 1990s
“Step-Function” Delta and Clinical/Statistical Issues
Merits of Existing Step-Function Approach -“One size” does not fit all
Many Effective Antibacterial Products Have Been Developed Since the Early 1990s Using This Approach
Implications of A Smaller Delta
Actual Example : Pediatric Meningitis Trial Investigational Drug vs. Active Control
What is Gained by Reducing Delta ?
Potential Disadvantages of a Fixed Margin Approach Regardless of the Response Rate of the Comparator
Unintended Consequences of Smaller Delta
Investigational Antibacterial Drugs are Already Disadvantaged in an R&D Portfolio
Suggested Principles for Selection of Delta
Specific Options for Delta: Options for Various Development Programs
Specific Options for Delta: Options for Various Development Programs
Example of “General Equivalence” Approach: Nosocomial Pneumonia (in 1992 FDA Points to Consider)
Study Design Options: Non-Life Threatening Infections with Spontaneous Cure (eg, acute bronchitis, AECB, acute otitis media)
Summary
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