Future of PrEP and Microbicide Research: Trial Design and Regulatory Issues

Background:

Materials and Links

Meeting Information:
• Agenda
• Participant List
• Evaluation
Presentations:
• Veronica Miller
• Kenneth Mayer
• Jim Rooney
• Jim Pickett
• Trip Gulick
• Sharon Hillier
• Charu Mullick
• Tom Fleming
• Deborah Donnell
• Jeff Murray

 

 

This meeting focused on clinical trial design and regulatory issues facing future PrEP and microbicide trials with topics including statistical challenges presented by various trial designs; potential (future) surrogate markers/systems; trial design options for different dosing and delivery modalities.

Status:
The meeting took place on January 7, 2013 in Washington, DC.

Steering Committee:

  • Roy (Trip) Gulick, Weill Cornell Medical Center
  • Benjamin Hauschild, Forum for Collaborative HIV Research
  • Kenneth Mayer, The Fenway Institute
  • Veronica Miller, Forum for Collaborative HIV Research
  • Jean-Michel Molina, ANRS
  • Jeffrey Murray, U.S. Food and Drug Administration
  • Alex Rinehart, ViiV Healthcare
  • Mitchell Warren, AIDS Vaccine Advocacy Coalition
  • Sheryl Zwerski, NIAID, Prevention Branch

Project Sponsors

gilead_logo viiv_healthcare_logo
   

For questions or additional information, please contact Ben Hauschild ( This e-mail address is being protected from spambots. You need JavaScript enabled to view it ).