The Army Medical Materiel Development Activity has awarded the Defense Health Agency’s (DHA) https://www.health.mil/dha funds to the University of California, San Francisco (UCSF).
UCSF will use the funds to conduct Phase 2 clinical trials on drugs needed to treat Traumatic Brain Injuries (TBI). UCSF will be the lead partner for the study titled “Transforming Research and Clinical Knowledge in the Traumatic Brain Injury Network” (TRACK-TBI NET.).
As many as 47 percent of veterans with TBI have symptoms such as sleep disturbances, headaches, depression, and memory deficits that can persist for years. The development of a drug to treat TBI could reduce secondary brain damage and improve the quality of life for the service members.
Despite years of research on the pathologies and symptoms caused by TBI, there are still no FDA approved drugs for treating the brain disorder. More than 30 drug trials for TBI have failed over the past few decades and the reasons for these failures are complex.
Researchers have suggested that more work should be done during the early exploratory trials to understand how drugs work and studies done to determine the right dose and timing of the drug. It has also been suggested that the way that clinical trials are conducted could improve by categorizing patients based on brain imaging and blood-based biomarkers, in order to help tailor each drug trial.
TRACK-TBI NET will characterize TBI candidate drugs in focused Phase 2 trials which will help the researchers understand the risks involved for Phase 3 trials. The goal is to work with industry and stakeholder groups to advance TBI drugs into Phase 3 and obtain FDA approval.
Also, the Defense Department and TRACK-TBI NET will work with FDA’s Center for Drug Evaluation and Research which sees the need to use alternative approaches to testing drugs and has released a request for public comment on this topic.
The Department of Defense (DOD) https:///defense.gov is also working with partners to improve both the quantity and quality of drugs that are in the pipeline for development to treat TBIs. As reported, public/private partnerships can leverage resources from stakeholders across DOD, Government, academia, non-profits, advocacy groups, and industry to work together to tackle this complex gap in healthcare.