Each year more than 2.5 million people in the U.S seek medical care for Traumatic Brain Injuries (TBI). According to CDC, an estimated 2 percent of the population now lives with TBI-caused disabilities at an annual cost of about $77 million So far, no treatment for acute TBI and concussion has proved to be effective.
A public-private partnership is being launched and funded by DOD with a $17 million for 5 years to produce better run clinical trials that may lead to the first successful treatments for TBI. The new research initiative, called the TBI Endpoints Development (TED) Award http://cdmrp.army.mil/funding/pa/13phtbited_pa-pdf will bring clinician-scientists together with leaders in biotechnology and imaging technology, patient advocacy organizations, and philanthropies.
According to University of California San Francisco’s Geoffrey T. Manley, MD, PhD, Chief of Neurosurgery at San Francisco General Hospital and Trauma Center https://sfgh.ucsf.edu and Principal Investigator for TED reports, “TBI lags 40 to 50 years behind heart disease and cancer in terms of progress and understanding of the actual disease process and its potential aftermath. More than 30 clinical trials of potential TBI treatments have failed, and not a single drug has been approved.”
TED will enlist collaboration with DOD, NIH, foundation-funded research networks, collaborate with co-sponsors such as GE, and patient advocacy groups to try to develop procedures, outcomes measures, and standards for interpreting clinical data.
The plan is to examine data from thousands of patients to identify effective measures of brain injury and recovery using biomarkers from blood, using new imaging equipment and software, plus using other tools.
TED is specifically designed to overcome the difficulty in demonstrating the effectiveness of TBI drugs and medical devices by actively involving the FDA in clinical-trial design from the outset.
Researchers will work directly with FDA to come up with better methods for selecting patients for clinical trials, and better ways to measure patient outcomes that may lead to the identification of effective TBI treatments. FDA’s “Critical Path Initiative” is going to approve new tools for drug and medical device development for use in the clinical trials.
“The discoveries derived from the TED initiative will produce medical technologies that are more effective, more affordable, and more accessible to people everywhere. GE is proud to be partnering with the TED research team,” said Robert Wells, Executive Director for Strategy for GE Healthymagination www.ge.com/about-us/healthymagination.
In addition, TED will also use the resources of the International Traumatic Brain Injury Initiative, a global TBI research and data-sharing consortium that includes the European Commission, Canadian Institutes of Health Research, along with NIH and DOD.
The research funded through an earlier $18.8 million NIH award called TRACK-TBI, has clinicians and biostatisticians at more than 20 institutions building a multi-dimensional database to integrate clinical, imaging, proteomic, genomic, and outcome biomarkers, collected within 24 hours after the injury.