To date, not a single drug or device has been approved by the FDA for the treatment of acute traumatic brain injury (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 the millions of people who suffer from TBI.
The National Institute of Neurological Disorders and Stroke funded TRACK-TBI (Transforming Research and Clinical Knowledge in TBI) study and the TBI Endpoints Development Initiative are working to change this.
Supported by One Mind, and partnering with 18 Level 1 trauma center enrollment sites across America, the TRACK-TBI (Transforming Research and Clinical Knowledge in TBI) study and the TBI Endpoints Development Initiative are working to change this.
Since launching, the TRACK-TBI study has collected detailed clinical data of over 3,000 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 a form required by the FDA for data submission. As a result, in March of 2017, the TRACK-TBI program received a ‘Letter of Support’ from the FDA for their imaging biomarker, and more recently in January of 2018, received a second FDA Letter of Support for their blood-based biomarker. To date, these are the only two Letters of Support issued by the FDA that relate to traumatic brain injury, thereby validating both the importance and the potential 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 in the end, provide precise targets for the development of new therapies and devices to treat TBI.
TRACK-TBI STUDY GOALS
To identify new diagnostic and prognostic markers and refine outcome assessments, which will lead to successful clinical treatment trials.
Why One Mind's Support Matters
One Mind has contributed $2.7 Million to TRACK-TBI and TED Initiative to advance brain health and assist in breaking down research silos and data sharing. One Mind gave this money to TRACK-TBI to ‘fill in the gaps’ in the original funding that the study received from the National Institute of Neurological Disorders and Stroke. A major focus of this funding was to cover the costs of providing a $125 per visit stipend to each of the 3,000+ patient participants. Not covered by federal funding, these stipends were used to reimburse the patients for their time and the cost of their transportation to and from the hospital, which was critically needed given the typically fragile physical state each TBI patient was in. As a result of the stipends, the patient return rate for the follow-up visits required within the 1-year study were 3-times as high as what they would have been otherwise. And thereby, the data obtained via the study was also amplified, significantly improving the information gained.
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