Effective treatment of TBI represents a great unmet need in public health. In 2013, approximately 2.8 million TBI-related emergency department (ED) visits, hospitalizations, and deaths occurred in the United States. TBI is a contributing factor in a third of all injury-related US deaths. Although there has been an increase in the understanding of the pathophysiology of TBI, to date, not a single successful clinical trial or treatment for TBI has occurred.
Launched with initial funding from the National Institute of Neurological Disorders and Stroke, and further supported by One Mind and other funding sources, the TRACK-TBI (Transforming Research and Clinical Knowledge in TBI) study and the TBI Endpoints Development Initiative aims to identify and confirm FDA approved diagnostic and prognostic markers that will lead to successful clinical treatment trials for TBI.
To do this, the TRACK-TBI study partnered with 18 Level 1 trauma center enrollment sites across America and 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 an FDA ‘Letter of Support’ for their imaging biomarker, and in January of 2018, the study 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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