Proceedings

Adherence to a study product is essential for the reliable evaluation of its efficacy and safety in a clinical trial. When adherence is poor, a potentially effective drug can be erroneously judged to be ineffective.  Pre-exposure prophylaxis (PrEP) trials for HIV prevention have been challenged by poor adherence. Given this and the fact that it is becoming more difficult to support the high cost of new drug development, the current model for clinical testing may no longer be sustainable. There is a clear need for cost-saving and efficient trial designs to test safety and efficacy. 

CONRAD, AVAC and the Forum for Collaborative HIV Research have joined forces to explore the potential of alternative trial designs.  On June 23, 2014, we convened a workshop on alternative trial designs for microbicides which generated lively discussion among more than 60 participants.  A number of possible designs were presented, as described in the attached proceedings.  Also attached is the agenda and a list of the participants.

The meeting co-sponsors have convened a subgroup to look at these designs, with the goal of selecting, revising, and implementing a study design.  In addition, a manuscript summarizing the concepts discussed at the meeting and presenting the selected design will be submitted for publication to a peer-reviewed journal.

For more information, please contact Christine Mauck, MD at  This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Additional Documents

FINAL AGENDA - Alternative Trial Design Workshop.pdf
Workshop on AlternativeTrial Designs for Microbicides.pdf

Presentations

Anneke Grobler.pdf
Ariane van der Straten.pdf
Benoit Masse.pdf
Craig Hendrix.pdf
Dionne Price.pdf
Gustavo Doncel.pdf
Jill Schwartz.pdf
Robert Cuffe.pdf
Sheena McCormack.pdf
Veronica Miller.pdf