Clinical Trial Design Issues
in the Development of Topical Microbicides
for the Reduction of HIV Transmission
•
•8:30 a.m. HIV and STIs in Women:                      Salim Karim, MBChB, Ph.D.
•                 The Urgent Need for an Efficacious                      University of Natal
•                 Microbicide                      Durban, South Africa
•
•8:50 a.m. Lessons Learned from COL-1492,                      Lut Van Damme, M.D., MSc.
• a Nonoxynol-9 Vaginal Gel Trial                      Contraceptive Research and
•                                                                                                                              Development Program (CONRAD)
•                                                Arlington, VA
•
•9:10 a.m. Considerations for Topical                     Teresa C. Wu, M.D., Ph.D.
• Microbicide Phase 2 and 3 Trial                     Medical Officer
• Designs, a Regulatory Perspective                     DAVDP, FDA
•
•9:30 a.m. Considerations for Topical                     Andrew Nunn, M.D.
• Microbicide Phase 2 and 3 Trial                     Medical Research Center
• Designs, an Investigator’s                     London, UK
• Perspective
•
•10:25 a.m. Statistical Considerations for                     Thomas Fleming, Ph.D.
• Topical Microbicide Phase 2 and                     Chair, Department of Biostatistics
• 3 Trial Designs, an Investigator’s                      University of Washington
• Perspective                      Seattle, WA
•
•10:50 a.m. Statistical Considerations for                     Rafia Bhore, Ph.D.
• Topical Microbicide Phase 2 and                     Mathematical Statistician
• 3 Trial Designs, a Regulatory                     Division of Biometrics, FDA
•              Perspective