AVAC/CONRAD/FORUM Workshop on Alternative Trial Designs for Microbicides

October 20, 2014

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

Additional Documents

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