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Clinical trials can only achieve their goals if participants use the product. A trial looking at safety or efficacy can’t gather information or draw conclusions if the trial volunteers choose not to follow the protocol—whether it is taking a drug, using a gel or returning for a follow-up injection of a vaccine. When adherence is poor, a potentially effective intervention can be judged to be ineffective—simply because people didn’t use it. Pre-exposure prophylaxis (PrEP) and microbicide trials for HIV prevention have been challenged by low product use among participants.
Given this and the fact that it is becoming more difficult to support the high cost of new drug development, 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 joined forces to explore the potential of alternative trial designs. On June 23, 2014, the groups convened a workshop on alternative trial designs for microbicides which generated lively discussion among more than 60 participants. The proceedings from this meeting are now available. Speaker slides are available here.
The workshop generated much lively discussion among its more than 60 participants. A number of possible designs were presented, as described in these proceedings. The meeting co-sponsors have convened a subgroup to look at these designs, with the goal of selecting, revising, and implementing a study design. A peer-reviewed publication summarizing the key points of discussion is also being prepared. AVAC will work with partners to translate these conversations into advocacy priorities and actions—contact us to learn more.