Food and Drug Administration

Anti-Infective Drugs Advisory Committee

February 19, 2002


Historical Perspective, Selection and Implications of Delta, Renata Albrecht, MD, Division of Special Pathogen and Immunologic Drug Products, FDA   ppt   htm

Active Control Non-Inferiority Studies: Theory, Assay Sensitivity, Choice of Margin, Robert J Temple, MD, Medical Policy, FDA   ppt   htm

Statistical Issues in Specification of /\, Daphne Lin, PhD, Erica Brittain, PhD, Dividion of Biometrics III, FDA   ppt   htm

Targeted Therapy for Fluoroquinolones in Infants and Children, George H McCracken Jr, MD, University of Texas Southwestern Medical Center at Dallas  ppt   htm

Selection of Delta to Determine Efficacy in Noninferiority Trials of Antibacterial Drugs, David Shlaes, MD, Antimicrobial Working Group of the Pharmaceutical Research and Manufacturers of American (PhRMA)   ppt   htm

Challenges in Antibacterial Drug Development, Francis P Tally, MD, Cubist Pharmaceuticals, Inc    ppt   htm

Issues Regarding Choice of the Margin in Non-Inferiority Trials, Thomas R Fleming, PhD, University of Washington   ppt   htm

Issues in Selection of Deltas in Non-Inferiority Trials:  Acute Bacterial Meningitis and Hospital-Acquired Pneumonia, John H Powers, MD, Division of Special Pathogen and Immunologic Drugs Products, FDA   ppt   htm

Selection of /\ in Clinical Trials of Antimicrobial Therapy - Acute Exacerbation of Chronic Bronchitis, Susan D Thompson, MD   ppt   htm

Delta Questions   ppt   htm

Open Public Hearing

Should the Non-Inferiority Margin Vary with the Comparation Rate? An Adaptive Statistical Test, Kem F Phillips PhD, Michael Corrado, MD, Advanced Biologics LLC   ppt   htm   doc