Center for Drug Evaluation and Research



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.
Chair, AIDAC

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
Boston University
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.
Medical Officer
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
Cleveland, Ohio

2:05 p.m. Summary and Charge to Committee Renata Albrecht, M.D.
Acting Director
Division of Special Pathogen
and Immunologic Drug
Products, FDA

2:15 p.m. Committee Discussion

2:30 p.m. Break

2:45 p.m. Committee Discussion and Vote

4:00 p.m. Adjourn