Traumatic Brain Injury (TBI) is a complex, and often chronic condition, not a one-time event. Each year more than 2.5 million people in the United States seek medical care for TBIs. According to the U.S. Centers for Disease Control and Prevention an estimated 2% of the U.S. population now lives with TBI-caused disabilities, at an annual cost of about $77 billion. The U.S. Department of Defense estimates that 313,816 brain injuries have been sustained by members of the U.S. military, worldwide, since 2000. As of 2015, no drug or device has been approved by the U.S. Food and Drug Administration (FDA) to treat acute TBI, and decades of well-designed clinical trials have failed. In large part, this disappointing progress stems from our inability to precisely diagnose this multi-factorial condition and thus, accurately stratify patients into trials that test drugs and devices relevant to their phenotypic injury.
Better designed clinical trials leading to the first successful treatments for traumatic brain injury are the goals of TBI Endpoints Development (TED) Initiative. With the support of a $17 million, five-year award from the Department of Defense (DoD), and direct collaboration with FDA, the TED team of leading academic clinician-scientists, along with innovative industry leaders in biotechnology and imaging technology, patient advocacy organizations, and philanthropies, will examine data from thousands of athletes, soldiers and the broader population to identify and validate effective measures or “endpoints” of brain injury and recovery.
First among TED’s objectives (Stage I) has been 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. We 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, through an open call for letters of intent for research projects, beginning July 1, 2015.
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