Unprecedented partnership joins universities, FDA, firms, philanthropies.
An unprecedented, public-private partnership funded by the Department of Defense (DoD) is being launched to drive the development of better-run clinical trials and may lead to the first successful treatments for traumatic brain injury, a condition affecting not only athletes and soldiers, but also millions among the general public, ranging from youngsters to elders.
Under the partnership, officially launched today (Oct. 1) with a $17 million, five-year award from the DoD, the research team, representing many universities, the Food and Drug Administration (FDA), 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.
Each year more than 2.5 million people in the U.S. seek medical care for traumatic brain injuries that arise when blows to the body or nearby explosions 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 treatment for acute TBI and concussion has proved to be effective.
“TBI is really a multifaceted condition, not a single event,” said UC San Francisco neurosurgeon Geoffrey T. Manley, M.D., Ph.D., principal investigator for the new award and chief of neurosurgery at San Francisco General Hospital and Trauma Center (SFGH), a UCSF partner hospital. “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.”
The new research initiative, called the TBI Endpoints Development (TED) Award, brings together leading academic clinician-scientists with innovative industry leaders in biotechnology and imaging technology, with patient advocacy organizations, and with philanthropies. The research collaborators will be collecting a broad range of long-term data from existing studies and databases, and integrating these 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 FDA in clinical-trial design from the outset.
Although awareness of TBI has focused on athletes and warriors, the condition is widely prevalent across all populations, due to falls and motor-vehicle and other accidents.
“We know that the problem is far more extensive than reported,” Manley said. “We have evidence that even those patients who arrive at emergency rooms with signs and symptoms that suggest they’ve sustained a brain injury often are released with no indication of a possible TBI entered into their medical records, and with no recommendation for follow-up care.”