Large-Scale, Open Science Research Works
TRACK/TBI and TED receives a second FDA Letter of Support
One Mind is on a mission to speed up discoveries in brain health through the principles of large-scale, open-science research. To prove this, we have been partnering with and supporting two large-scale, multi-centered, longitudinal studies that we believe represent the most promising opportunity to advance this intent.
The collaborations include the 3,000 person Transforming Research and Clinical Knowledge in Traumatic Brain Injury / TBI Endpoints Development Initiative (TRACK-TBI/TED) studies and the 5,000 person AURORA study on trauma-related brain illness and post-traumatic stress. Both collaborations are important fundraising priorities for One Mind and both collaborations have recently achieved significant successes that help solidify their status as truly being paradigm-shifting. Through their work to date, these collaborations continue to move closer to their respective goals of confirming FDA-approved biomarkers that will hopefully soon aid in the development of diagnostics and treatments for their respective brain-related conditions.
On January 10th of this year, the TED Initiative, along with TRACK-TBI, received a coveted FDA Letter of Support for the study’s blood-based biomarkers. The Letter of Support encourages the TRACK-TBI/TED program to continue their work in studying the blood biomarkers, that when in use could help to identify patients at risk for persistent and long-term negative outcomes during the course of TBI clinical trials. Of equal significance, the Letter of Support is a call-out to the world by the FDA endorsing the TRACK-TBI/TED’s intentional efforts to leverage data across studies, to pay stringent attention to the use of data standards, to share data openly, and to adhere to their analytical processes – all of which are priorities that One Mind strongly supports.
This Letter of Support from the FDA is the second received by the TRACK-TBI/TED collaboration, and complements the first one received in March 2017 for their neuroimaging prognostic biomarkers. Together, they represent the only two Letters of Support issued by the FDA related to traumatic brain injury, which reconfirms the uniqueness of the paradigm-shifting work that the TRACK-TBI/TED collaboration continues to do.
To date, not a single drug or device has been approved by the FDA for the treatment of acute traumatic brain injury (TBI). One Mind is spurred on by the progress that the TRACK-TBI/TED collaboration has made and we remain steadfast in our efforts to raise funds to support their efforts to expedite diagnostics and treatments for the millions of people who live with the disabilities caused by TBI.