A Standardized Approach to Early-Phase, Proof-of-Concept Therapeutic Trials in DengueThis Perspective article reflects discussions held at the 1 st International Dengue Therapeutics Workshop, held in Ho Chi Minh City, Vietnam in September 2011, attended by participants from academia and industry, and focused on recent experience from several randomized controlled clinical trials of candidate dengue therapeutic agents [1,2,3].The aim of this article is to provide an informed set of recommendations for the design and conduct of early-phase clinical trials where safety and antiviral efficacy are the endpoints of interest.The focus for this article is on early-phase testing of antiviral therapies because this is where most drug development efforts in academia and industry are directed.Establishing a standardized and consistent framework for dengue therapeutic trials will facilitate better data management and analytical practices and ensure that clinical data can be readily collated and made available for pooled analyses.
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