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 study is collecting detailed clinical data of 3,000 TBI injured patients, following the progression of their injuries for a year.
TRACK-TBI and TED collected the data to date 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.
In addition, dataset created via the study 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.
This said, more work needs to be done. In response, One Mind intends to continue its financial support of the TRACK-TBI study. With the interest of confirming actual treatments and therapies for the millions of people who live with the disabilities caused by TBI, we ask that you make a donation to One Mind in support of this study.