FOOD AND DRUG ADMINISTRATION
Center for Drug Evaluation and Research
ANTIVIRAL DRUGS ADVISORY COMMITTEE (AVAC) MEETING
Agenda
Holiday Inn,
Clinical Trial
Design Issues
in the Development of Topical
Microbicides
for the Reduction of HIV Transmission
Chair,
AVAC
Introduction of
Committee
Conflict of Interest
Statement Tara
P. Turner, Pharm.D.
Executive
Secretary, AVAC
Director
Division
of Antiviral Drug Products
FDA
The Urgent Need for an Efficacious Director, Centre for the AIDS
Microbicide Programme of
Research in
a Nonoxynol-9 Vaginal Gel Trial International Clinical
Research Manager
Contraceptive Research and Development Program
(CONRAD)
Microbicide Phase 2 and 3 Trial Medical
Officer
Designs, a Regulatory Perspective Division of Antiviral Drug
Products
FDA
Microbicide Phase 2 and 3 Trial Head,
Division Without Portfolio
Designs, an Investigator’s Medical
Research Council
Perspective Clinical
Trials Unit
Topical Microbicide Phase 2 and Professor and Chair
3 Trial Designs, an Investigator’s Department of Biostatistics
Perspective
Topical Microbicide Phase 2 and Mathematical
Statistician
3 Trial Designs, a Regulatory Division
of Biometrics
Perspective FDA
Questions for Discussion