FOOD AND DRUG ADMINISTRATION
Center for Drug Evaluation and Research
ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE (AIDAC) MEETING
July 11, 2002
Marriott Washingtonian Center, Grand Ballroom, 9751 Washingtonian Blvd., Gaithersburg, MD
Topic: Clinical trial design for studies of otitis media
8:30 a.m. Call to Order L. Barth Reller, M.D.
Introduction of Committee
Conflict of Interest Statement Tara P. Turner, Pharm.D.
Executive Secretary, AIDAC
8:40 a.m. Guidance Development John H. Powers, M.D.
Lead Medical Officer for
Antimicrobial Drug Development
Office of Drug Evaluation IV
8:50 a.m. Development of Antibiotics for Janice M. Soreth, M.D.
Otitis Media: Past, Present and Future Director
Division of Anti-Infective Drug Products, FDA
9:10 a.m. Design Issues in Antimicrobial G. Scott Giebink, M.D.
Treatment Trials of AOM Professor
Department of Pediatrics
University of Minnesota
9:30 a.m. Experience with Tympanocentesis/ Michael Pichichero, M.D.
Clinical Diagnosis of AOM Professor of Microbiology, Immunology, Pediatrics and Medicine
University of Rochester
9:55 a.m. Double Tympanocentesis Studies Ron Dagan, M.D.
Pediatric Infectious Diseases Unit
Soroka Medical Center
10:25 a.m. Limitations of Clinical-only Studies Colin Marchant, M.D.
Adjunct Associate Professor
School of Medicine
10:50 a.m. Break
11:05 a.m. Study Designs for Acute Otitis Media Trials: C. George Rochester, Ph.D.
What can each design tell us? Statistician
Division of Biometrics III
11:25 a.m. Lesson Learned from Past Approvals Thomas Smith, M.D.
Division of Anti-Infective
Drug Products, FDA
11:45 a.m. Study Considerations: Rosemary Johann-Liang, M.D.
Recurrent / Treatment Failure AOM Medical Officer
Division of Special Pathogen and
Immunologic Drug Products
12:05 p.m. Lunch
1:05 p.m. Open Public Hearing
Michael R. Jacobs, M.D., Ph.D.
Case Western Reserve University
University Hospitals of Cleveland
2:05 p.m. Summary and Charge to Committee Renata Albrecht, M.D.
Division of Special Pathogen
and Immunologic Drug
2:15 p.m. Committee Discussion
2:30 p.m. Break
2:45 p.m. Committee Discussion and Vote
4:00 p.m. Adjourn