Effective treatment of traumatic brain injury represents a great unmet need in public health.
As proof, to date not a single drug or device has been approved by the FDA for the treatment of acute TBI. This is because most drug companies consider the development of drugs to treat neurodegenerative injuries too risky because biologically based diagnostics that allow stratification of TBI patients for clinical trials do not exist.
These delays are unacceptable and a solution must be discovered to aid those who suffer from TBI.
The National Institute of Neurological Disorders and Stroke funded TRACK-TBI study and the TBI Endpoints Development Initiative working to change this. Partnering with One Mind and 18 enrollment sites across America, the TRACK-TBI study is collecting detailed clinical data of TBI injured patients. To date, the study has enrolled over 2,000 TBI injured patients, following the progression of their injuries for a year.
TRACK-TBI and TED collected the data according to NIH/NINDS Common Data Standards (CDEs) which were later converted to CDISC approved CDEs, with funds provided by One Mind, as required by the FDA for data submission. This rich and diverse precision medicine dataset will reside in a publicly accessible infrastructure of integrated databases, imaging repositories, and biosample repositories, creating a true TBI Information Commons that can be used by the best TBI focused scientists throughout the world.
a result, in March of 2017, the TRACK-TBI program received a ‘Letter of Support’ from the FDA for their imaging biomarker that validates the importance of this largest ever study of TBI.
The biomarkers being developed via the TRACK-TBI and TED studies will enable stratification of the concussion population and define concussion sub-types, thereby enabling researchers to more effectively match patients to clinical trials and provide precise targets for the development of new therapies.
Through this collaboration, TRACK-TBI, TED and One Mind are demonstrating the power of real team science and clinician researchers who focus on the welfare of their patients before personal reward.
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Traumatic Brain Injury Statistics:
As is, at least 2.8 million Americans suffer from a traumatic brain injury each year and traumatic brain injuries are a factor in one-third of all injury-related U.S. deaths.
Traumatic brain injuries affect all demographics including civilians and military personnel alike with an estimated 3.2 to 5.3 million Americans live with the long-term disabilities caused by TBI.
And the estimated annual direct and indirect cost of treating traumatic brain injuries in America is more than $76 billion.