FOOD AND DRUG ADMINISTRATION
Center for Drug Evaluation and Research
ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE (AIDAC) MEETING
February 19, 2002
Holiday Inn, Two Montgomery Village Avenue, Gaithersburg, MD
Topic: Proposed approach for selection of delta in non-inferiority (equivalence) clinical trials
8:00 a.m. Call to Order and Introductions L. Barth Reller, M.D.
8:05 a.m. Conflict of Interest Statement Tara P. Turner, Pharm.D.
Executive Secretary, AIDAC
8:10 a.m. Opening Comments Mark Goldberger, M.D., M.P.H.
Office of Drug Evaluation IV,
8:15 a.m. Historical Perspective, Selection and Renata Albrecht, M.D.
Implications of Delta Acting Director
Division of Special Pathogen and
Immunologic Drug Products,
8:35 a.m. Active Control Non-Inferiority Studies: Robert Temple, M.D.
Theory, Assay Sensitivity, Choice of Margin Associate Director for
Center for Drug Evaluation and
8:55 a.m. Statistical Issues in Specification of Delta Daphne Lin, Ph.D.
Statistical Team Leader, FDA
Erica Brittain, Ph.D.
Statistical Reviewer, FDA
9:35 a.m. Break
9:50 a.m. Medical Perspective: Bacterial Meningitis George H. McCracken, Jr., M.D.
University of Texas Southwestern
Medical Center at Dallas
10:15 a.m. Industry Presentation (PhRMA) David Shlaes, M.D.
Catherine Hardalo, M.D.
Lianng Yuh, Ph.D.
Christy Chuang-Stein, Ph.D.
10:45 a.m. Industry Presentation Francis Tally, M.D.
11:15 a.m. IDSA Presentation Vincent T. Andriole, M.D.
George H. Talbot, M.D.
Dennis D. Wallace, Ph.D.
John E. Edwards, Jr., M.D.
11:45 a.m. Issues Regarding Choice of the Margin Thomas R. Fleming, Ph.D.
in Non-Inferiority Trials University of Washington
12:00 p.m. Lunch
1:00 p.m. Open Public Hearing
Kem Phillips, Ph.D. – Advanced Biologics, LLC
(Statement for the Record)
1:30 p.m. Medical Perspective: John Powers, M.D.
Hospital Acquired Pneumonia/Meningitis Medical Officer
Division of Special Pathogen and Immunologic Drug Products,
1:55 p.m. Medical Perspective: Susan Thompson, M.D.
Acute Exacerbation of Chronic Bronchitis Medical Officer
Division of Anti-Infective
Drug Products, FDA
2:20 p.m. Break
2:35 p.m. Summary and Charge to Committee Mark Goldberger, M.D., M.P.H.
2:50 p.m. Committee Discussion
5:30 p.m. Adjourn