Food and Drug Administration
August 20, 2003
Slides
Topical Microbicides, Dr. Birnkrant, FDA (HTM) (PPT)
HIV/AIDS and STIs in Women: The Urgent Need for an Efficacious Microbicide, Salim Abdool Karim, University of Natal (HTM) (PPT)
Lessons Learned From the Phase III Trial of Col-1492, A Nonoxynol-9 Vaginal Gel, on HIV-1 Transmission in Female Sex Workers, Lut Van Damme, GMP (HTM) (PPT)
Considerations for Topical Microbicide Phase 2 and 3 Trial Design: A Regulatory Perspective, Dr. Teresa Wu, MD, PhD, FDa (HTM) (PPT)
Considerations for Topical Microbicide Phase 3 Trial Designs, An Investigator's Perspective, Andrew Nunn, Medical Research Council, London, UK (HTM) (PPT)
Some Design Issues in Microbicide Trials, Dr. Thomas Fleming, PhD, University of Washington (HTM) (PPT)
Statistical Considerations for Topical Microbicide Phase 2 and 3 Trial Designs: A Regulatory Perspective, Dr. Rafia Bhore, Phd, & Dr. Greg Soon, PhD, FDA (HTM) (PPT)
Open Public Hearing
Presentation from Biosyn, Richard Bax (HTM) (PPT)
Core Issues in Microbicide Clinical Trial Design: A Consensus Perspective, Dr. Polly Harrison, PhD on behalf of the Ad Hoc Subcommittee of the Alliance for Microbicide Development (HTM) (PPT)
Clinica Trial Design Issues in the Development of Topical Microbicides for the Reduction of HIV Transmission, Dr. Polly Harrison, Written on behalf of the Ad Hoc Subcommittee of the Alliance for Microbicide Development (HTM) (PDF) (Word)
Microbicide Products in Clinical Trials, Dr. Polly Harrison, PhD, Written on behalf of the Ad Hoc Subcommittee of the Alliance for Microbicide Development (PDF)
Microbicide Products in Development by Primary Mechanism of Action (May 2003), Dr. Polly Harrison, PhD, Written on behalf of the Ad Hoc Subcommittee of the Alliance for Microbicide Development (PDF)
Rectal Microbicide Development, Dr. Ian McGowan, MD, PhD, UCLA (HTM) (PPT)
Microbicides The Population Council Experience and Future Directions, Don Waldron, Population Council (HTM) (PPT)
Clinical Trial Design Issues in Development of Topical Microbicides, Tim Farley, World Health Organization, Geneva, Switzerland (HTM) (PPT)
Measures of Porduct Effect, Choice of Control Arms, and Strength of Evidence Necessary to Demonstrate Effectiveness, Tim Farley, WHO (HTM) (PDF) (Word)
Design of Phase III Microbicide Trials: Choice of Control Group, Dr. Rosalie Dominik, DrPH, Family Health International (HTM) (PPT)
Comparing an Experimental Microbicidal Product to Placebo and to "Condom Only," Zena Stein (HTM) (PPT)
Memorandum From Zena Stein to Tara Turner (HTM) (PDF) (Word)
Statement of the Global Campaign for Microbicides, Dr. Forbes (HTM) (PPT)
Hypothetical Outcomes, Relative Risks and Likely Regulatory Response to a Randomized Control Trial Comparing Microbicidal Product With Placebo and to "Condom Only" Arm, Dr. Forbes (HTM) (PDF) (Word)
Letter to Tara Turner, PharmD From Dr. Robert Munk, PhD, et.al.(HTM) (PDF) (Word)
Testimony Submitted by Laurie Sylla, MHSA, BSW, Yale School of Nursing (HTM) (PDF) (Word)