The TBI Endpoints (TED) Initiative held its first Consensus Conference on February 2-3, 2015 at the NIH campus in Bethesda, MD. The TED Initiative, a five-year program funded by the U.S. Department of Defense, will curate and harmonize data from a variety of legacy and ongoing military, civilian, and sport TBI cohorts into a Metadataset that can be interrogated for associations between clinical, proteomic, genomic, and imaging findings that smaller individual studies were not powered or designed to find. The Initiative will also analyze the landscape of blood-based biomarkers, neuroimaging biomarkers, clinical outcome assessments, and emerging technologies as to their utility and regulatory readiness to serve as endpoints or qualified drug or device development tools for TBI diagnostic and therapeutic drug and device trials. Prime candidates will be analyzed in validation trials funded by the TED Initiative and from external investigator-initiated sources of support. At the Conference, leading figures in TBI research, along with senior regulatory partners from the FDA, and industry representatives collaborated over two days of presentations and roundtable discussions on regulatory processes, reports from the field, and the convening of Expert Working Groups to begin the landscape analyses. The Conference was the first of an ongoing portfolio of activities to facilitate early and meaningful collaboration with regulators on the selection of candidates and design of methodologies to explore TBI clinical outcomes, biomarkers, and emerging technology devices aimed at developing new diagnostic and therapeutic tools for TBI patients.
To receive follow up materials from this conference or to be put on the TRACK-TBI or TED mailing list, please contact Brian Fabian.