TRACK-TBI receives FDA Letter of Support

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It is with great pride and excitement that we share with you the news of a significant milestone recently reached by the One Mind supported TRACK-TBI and TBI Endpoints Development (TED) Initiative studies that advances our mutual goal of bringing better diagnostics and treatment to the millions of people who suffer the long-term disabilities resulting from TBI.

The TRACK-TBI and TED studies are partially funded by the National Institutes of Health and the Department of Defense. The centerpiece of these two studies is the collection of detailed clinical data from 3,000 TBI injured patients and early collaboration with the Food & Drug Administration (FDA) to champion new FDA approved TBI diagnostics and therapies. With financial support from One Mind, the TRACK-TBI and TED studies were able to collect data according to the National Institutes of Health data standards and convert the data into a submission format acceptable to the FDA.

As a result, in March of 2017, the FDA presented the TRACK-TBI and TED studies with a much-coveted Letter of Support for the program’s magnetic resonance imaging biomarker. In providing the letter, the FDA publically acknowledged the integrity of the study data collected to date, the significance of the collaboration and integration across trials to accelerate drug development programs for TBI, and the collaborators’ plans to move forward with use of its imaging biomarkers to identify individuals with mild TBI who may go on to experience persistent and long-term negative outcomes.

In addition, the TRACK-TBI and TED investigators are also working collaboratively with Abbott to gain FDA clearance of blood biomarker tests that would be used on Abbott’s handheld i-STAT system. With two to three drops of blood, the blood biomarkers could help evaluate concussion within 15 minutes. Besides being an obvious aid to ER doctors, this point of care device has the potential to help clinicians make informed return to play decisions on the football field and other sports venues.

Biologically-based diagnostics are vital to the industry because they will allow stratification of the patient population for studies of potential new treatments, thereby improving the chances of success and reducing the risk of failure in developing new drugs, devices and treatments for traumatic brain injury.

Although great progress has been made, there is still plenty of work the studies need to complete. To help, One Mind intends to raise an additional $5.2 million over the next two years to be given to the TRACK-TBI /TED programs. Help those who suffer from TBI by making a donation to One Mind today!

Learn more about the TRACK-TBI and TED studies.