title: The Traumatic Brain Injury Endpoints Development (TED) Initiative: Progress on a Public-Private Regulatory Collaboration To Accelerate Diagnosis and Treatment of Traumatic Brain Injury.
abstract: The Traumatic Brain Injury Endpoints Development (TED) Initiative is a 5-year, Department of Defense-funded project that is working toward the ultimate goal of developing better designed clinical trials, leading to more precise diagnosis, and effective treatments for traumatic brain injury (TBI). TED is comprised of leading academic clinician-scientists, along with innovative industry leaders in biotechnology and imaging technology, patient advocacy organizations, and philanthropists, working collaboratively with regulatory authorities, specifically the U.S. Food and Drug Administration (FDA). The goals of the TED Initiative are to gain consensus and validation of TBI clinical outcome assessment measures and biomarkers for endorsement by global regulatory agencies for use in drug and device development processes. This article summarizes the Initiative's Stage I progress over the first 18 months, including intensive engagement with a number of FDA divisions responsible for review and validation of biomarkers and clinical outcome assessments, progression into the prequalification phase of the FDA's Medical Device Development Tool program for a candidate set of neuroimaging biomarkers, and receipt of the FDA's Recognition of Research Importance Letter and a Letter of Support regarding TBI. Other signal achievements relate to the creation of the TED Metadataset, harmonizing study measures across eight major TBI studies, and the leadership role played by TED investigators in the conversion of the NINDS TBI Common Data Elements to Clinical Data Interchange Standards Consortium standards. This article frames both the near-term expectations and the Initiative's long-term vision to accelerate approval of treatments for patients affected by TBI in urgent need of effective therapies.
authors.affiliation: Department of Neurological Surgery, University of California San Francisco, Zuckerberg San Francisco General Hospital and Trauma Center, and the Brain and Spinal Injury Center, University of California San Francisco, San Francisco, California.
authors.forename: Geoffrey T
authors.initials: GT
authors.lastname: Manley
authors.affiliation: Department of Neurological Surgery, University of Washington, Seattle, Washington.
authors.forename: Christine L
authors.initials: CL
authors.lastname: Mac Donald
authors.affiliation: Department of Neurological Surgery, University of California San Francisco, Zuckerberg San Francisco General Hospital and Trauma Center, and the Brain and Spinal Injury Center, University of California San Francisco, San Francisco, California.
authors.forename: Amy J
authors.initials: AJ
authors.lastname: Markowitz
authors.affiliation: Critical Path Institute, Tucson, Arizona.
authors.forename: Diane
authors.initials: D
authors.lastname: Stephenson
authors.affiliation: Critical Path Institute, Tucson, Arizona.
authors.forename: Ann
authors.initials: A
authors.lastname: Robbins
authors.affiliation: Department of Neurology, University of California San Francisco, San Francisco, California.
authors.forename: Raquel C
authors.initials: RC
authors.lastname: Gardner
authors.affiliation: Department of Neurological Surgery, University of California San Francisco, San Francisco, California.
authors.forename: Ethan
authors.initials: E
authors.lastname: Winkler
authors.affiliation: Department of Physical Medicine and Rehabilitation, Harvard Medical School, Charlestown, Massachusetts.
authors.forename: Yelena G
authors.initials: YG
authors.lastname: Bodien
authors.affiliation: Department of Neurological Surgery, University of California San Francisco, Zuckerberg San Francisco General Hospital and Trauma Center, and the Brain and Spinal Injury Center, University of California San Francisco, San Francisco, California.
authors.forename: Sabrina R
authors.initials: SR
authors.lastname: Taylor
authors.affiliation: Department of Neurological Surgery, University of California San Francisco, Zuckerberg San Francisco General Hospital and Trauma Center, and the Brain and Spinal Injury Center, University of California San Francisco, San Francisco, California.
authors.forename: John K
authors.initials: JK
authors.lastname: Yue
authors.affiliation: Emergency Preparedness/Operations and Medical Countermeasures Program, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Lakshmi
authors.initials: L
authors.lastname: Kannan
authors.affiliation: Independent consultant.
authors.forename: Allison
authors.initials: A
authors.lastname: Kumar
authors.affiliation: Department of Neurosurgery, Medical College of Wisconsin, Milwaukee, Wisconsin.
authors.forename: Michael A
authors.initials: MA
authors.lastname: McCrea
authors.affiliation: Program for Neurotrauma, Neuroproteomics & Biomarker Research, Department of Psychiatry, McKnight Brain Institute, University of Florida, Gainesville, Florida.
authors.forename: Kevin K
authors.initials: KK
authors.lastname: Wang
keywords: CT; FDA; MRI; biomarkers; clinical outcome measures; traumatic brain injury