TBI Endpoints Development (TED) Award
Department of Defense
TBI is a multifaceted condition, and as of 2015, no drug or device has been approved by the U.S. Food and Drug Administration (FDA) to treat acute TBI. In collaboration with the FDA, TBI Endpoints Development (TED) researchers will examine existing datasets from thousands of athletes, soldiers and the broader population to identify which current measures are most effective, and validate these measures or “endpoints” of brain injury and recovery. The TED team is comprised of leading academic clinician-scientists, industry leaders in biotechnology and imaging technology, patient advocacy organizations, and philanthropies.The lead site is the University of California, San Francisco.
First among TED’s objectives (Stage I) is to establish a TED Metadataset consisting of integrated clinical outcomes, and imaging, proteomic, and genomic data, from ongoing and legacy TBI studies across civilian, military, and sports cohorts. This highly detailed and multi-scalar repository will be continuously curated and analyzed using conventional and novel methodologies. TED researchers aim to identify and validate meaningful TBI endpoints, as well as structural abnormalities that may be predictive of outcomes, making strides toward a new taxonomy for TBI.
Among other objectives (Stage II) TED will support the selection, funding, and oversight of four Seed Projects focused on validation of clinical outcome assessments (COAs) and blood-based and neuroimaging biomarkers. Creating a range of validated COAs, biomarkers, and devices will:
- Permit more accurate disease/condition diagnosis
- Identify patient subpopulations likely to benefit from therapy/intervention
- Provide refined outcome assessments to confirm efficacy
For more information about the TED Initiative, click here.