U.S. Aims for TBI Clinical Trial Success

An unprecedented, public-private partnership is being launched to drive the development of better-run clinical trials that could 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. Under the partnership, 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. “TBI is really a multifaceted condition, not a single event,” said the lead investigator of the study. “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 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. To read more about this study, click here.