NIH 2014 Chronic GVHD Consensus Project on Criteria for Clinical Trials

Chronic GVHD (cGVHD) is an area of profound unmet need. Currently there are no FDA approved therapeutics for cGVHD, and the incidence of this complication among the transplant patient population is rising. The purpose of this one day conference is to provide a set of updated evidence-based recommendations for the conduct of cGVHD clinical trials and research. During the period of 2004-2006, the original NIH cGVHD Consensus Project provided expert-driven recommendations, which were summarized in six papers covering key areas: diagnosis and staging; histopathology; biomarkers; response criteria; ancillary and supportive care and design of clinical trials. These papers have been cited more than 1400 times in peer-reviewed literature. The research field in cGVHD is now better organized and research momentum has intensified. However, there is a need for evidence-based refinements and clarifications of the original recommendations.

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