Treating traumatic brain injury (TBI) remains one of the top priorities for the Department of Defense (DoD). The DoD and the military services require solutions to fill the capability gap to treat TBI as close to point of injury as possible, to reduce primary and secondary brain damage. The current standard of care for TBI remains supportive in nature, based on management of symptoms, with no drug therapies that address the brain damage. Despite numerous clinical trials on potential therapies, there is no U.S. Food and Drug Administration (FDA) approved drug therapy for the treatment of TBI. TBI has been shown to increase long-term mortality and reduce life expectancy. Estimated economic costs of care for TBI are >$75B per year according to the Centers for Disease Control (CDC). Therefore, it is important to develop a therapy that will decrease lost duty time and mitigate the life-long disability and rehabilitation costs associated with these post-injury conditions.
The intent of the DoD Drug Treatment for TBI (DTTBI) program is to improve the quality and quantity of candidate drugs entering Phase 3 trials for the treatment of moderate to severe TBI. The objective of this award is to leverage the capabilities of an existing clinical trial network with proven capability to recruit individuals with TBI, and to enable a TBI clinical consortium that can rapidly execute multiple FDA regulated Phase 2 clinical trials intended to fully characterize drug candidates prior to entering Phase 3 trials.
The deliverable at the end of the award is to demonstrate efficacy of at least one TBI candidate drug in Phase 2 clinical trials and recommend its continued development toward FDA regulatory clearance.
The research project award recipient was selected from the Offerors who responded to MTEC’s Request for Project Proposals (18-03-DTTBI).
TRACK-TBI NETWORK (TRACK-TBI NET)
Project Team: University of California, San Francisco (prime organization); University of Pennsylvania; Harvard Medical School-Spaulding Rehabilitation Hospital; University of California, San Diego; Medical College of Wisconsin; University of Pittsburgh Medical Center; Baylor College of Medicine; University of California, San Diego; University of Washington
Award Amount: $26.2 million
Project Duration: 5 years
Project Objective: TRACK-TBI NET is an innovative, precision medicine driven network that will test Phase 2 drugs for traumatic brain injury (TBI). The network builds on the well-established infrastructure of TRACK-TBI, which has enrolled over 3,000 patients and controls at 18 level 1 trauma centers across the country over the past 5 years.