$17 million award allows VCU, partners to improve clinical trials for traumatic brain injury

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Researchers at Virginia Commonwealth University are part of a public-private partnership funded by the Department of Defense to improve clinical trials in the hope of successfully treating traumatic brain injury, which affects athletes, soldiers and millions of others.

The partnership was announced earlier this month with a $17 million, five-year award from the DoD. The research team, representing many universities, the Food and Drug Administration, companies and philanthropies, will examine data from thousands of patients in order to identify effective measures of brain injury and recovery, using biomarkers from blood, new imaging equipment and software, and other tools.

“Based on the abundant amount of clinical research that’s been done on patients who have suffered a mild or severe TBI, it has become increasingly clear that even a mild TBI (concussion) can trigger chronic and wide-ranging adverse physical, cognitive and neurobehavioral changes for months and even years after the injury,” said Randall E. Merchant, Ph.D., executive director of the VCU Center for Rehabilitation Science and Engineering and co-principal investigator for the grant at VCU.

“We are hampered by the lack of reliable diagnostic tools which can predict who among our TBI patients will or will not make a complete recovery. Furthermore, there is no single outcome measurement tool or endpoint which can capture the full range of these effects over time nor mitigate all concerns,” Merchant said.

The new research initiative, called the TBI Endpoints Development (TED) Award, joins leading academic clinician-scientists, industry leaders in biotechnology and imaging technology, patient advocacy organizations, and philanthropies. Researchers will collect a broad range of long-term data from existing studies and databases for integration into a dataset that can be interrogated for TBI associations and causes in a way that has never before been possible.

TED is specifically designed to overcome the difficulty in demonstrating the effectiveness of TBI drugs and medical devices by actively involving the Food and Drug Administration in clinical-trial design from the outset.

The research collaborators will work directly with the 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.

Each year, more than 2.5 million people in the U.S. seek medical care for traumatic brain injuries from blows to the body or nearby explosions, which cause the brain to collide with the inside of the skull. According to the U.S. Centers for Disease Control and Prevention, an estimated 2 percent of the U.S. population now lives with TBI-caused disabilities, at an annual cost of about $77 billion. No TBI treatment has proved to be effective.

“The TED project will help to shape the landscape of future TBI research by establishing universal, standard outcome measurement tools for all future federally funded TBI research,” said David X. Cifu, M.D., professor and chairman of the Department of Physical Medicine and Rehabilitation and co-principal investigator for the grant. “This will be important for sports, military and civilian injuries of all types from concussion to coma. As we have for the past 40 years, VCU is contributing to and leading the way in TBI research that will affect millions around the world for generations.”

The Department of Physical Medicine and Rehabilitation is helping to guide the VCU neurosciences research activities through the VCU Center for Rehabilitation Science and Engineering.

TED is the third grant VCU has been awarded to study TBI since August 2013 and the university is already an important player in two large multi-institutional clinical research networks established to study traumatic brain injury (TBI); the CENC (Chronic Effects of Neurotrauma Consortium) and the TRACK-TBI Consortium (Transforming Research and Clinical Knowledge in TBI) headed up here by David Cifu, M.D., and Randall Merchant, Ph.D., respectively. While these consortia have nonoverlapping aims, both share the goals and priorities of the TED program.


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