FOOD AND DRUG ADMINISTRATION

Center for Drug Evaluation and Research

ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE (AIDAC) MEETING

AGENDA

October 29, 2003

Holiday Inn, The Ballrooms, Two Montgomery Village Avenue, Gaithersburg, MD

Topic: Clinical trial design in Acute Bacterial Sinusitis (ABS)

8:30 a.m. Call to Order James E. Leggett, Jr., M.D.

Chair, AIDAC

Introduction of Committee

Conflict of Interest Statement Tara P. Turner, Pharm. D.

Executive Secretary, AIDAC

8:40 a.m. General Overview: Antimicrobial Renata Albrecht, M.D.

Development for ABS, Director

Regulatory History Division of Special Pathogen

and Immunologic Drug Products, FDA

9:00 a.m. Acute Bacterial Sinusitis: Overview Jack M. Gwaltney, Jr., M.D.

Professor Emeritus, Division Head

Division of Epidemiology and Virology

University of Virginia

9:40 a.m. Description of Sinus Puncture Thomas A. Sydnor, Jr., M.D.

Otolaryngologist

Virginia Medical Studies (Retired)

10:00 a.m. Statistical Considerations in Clinical Trial Thomas R. Fleming, Ph.D.

Design in ABS Professor and Chair

Department of Biostatistics

University of Washington

10:30 a.m. Break

10:45 a.m. Clinical Evaluation of ABS: Carl Kraus, M.D.

Diagnostic Considerations Medical Officer

Division of Special Pathogen and

Immunologic Drug Products, FDA

11:15 a.m. Lesson Learned from Clinical Trial Janice Pohlman, M.D.

Design in Past Approvals Medical Officer

Division of Anti-Infective Drug Products

FDA

11:45 a.m. Clinical Trial Design in ABS: John H. Powers, M.D.

Considerations for Future Guidance Lead Medical Officer for

Antimicrobial Drug Development

Office of Drug Evaluation IV, FDA

12:15 p.m Lunch

1:15 p.m. Open Public Hearing

1:45 p.m. Charge to Committee Edward Cox, M.D., M.P.H.

Deputy Director

Office of Drug Evaluation IV, FDA

1:50 p.m. Committee Discussion

4:30 p.m. Adjourn

QUESTIONS TO THE COMMITTEE

1. How does one ensure that patients in clinical trials of acute bacterial sinusitis have bacterial disease? Please discuss the methods of obtaining microbiologic data including sinus punctures and nasal endoscopy.

2. Please discuss the issues of trial design in the study of acute bacterial sinusitis. Please include in your discussion:
1. the strengths and limitations of placebo-controlled trials and non-inferiority trials. Please discuss how one determines a non-inferiority margin in non-inferiority trials for this indication.
2. the strengths and limitations of comparative microbiologic data.

3. Please discuss the issues of measuring outcomes in patients in trials of acute bacterial sinusitis. Please include in your discussion measuring time-to-resolution of symptoms as an endpoint compared to fixed endpoints.