The Traumatic Brain Injury Endpoints Development (TED) initiative: progress on a public-private regulatory collaboration to accelerate diagnosis and treatment of …

GT Manley, CL Mac Donald, AJ Markowitz… - Journal of …, 2017 - liebertpub.com
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 …

Transforming research and clinical knowledge in traumatic brain injury pilot: multicenter implementation of the common data elements for traumatic brain injury

JK Yue, MJ Vassar, HF Lingsma, SR Cooper… - Journal of …, 2013 - liebertpub.com
Traumatic brain injury (TBI) is among the leading causes of death and disability worldwide,
with enormous negative social and economic impacts. The heterogeneity of TBI combined …

Paths to successful translation of new therapies for severe traumatic brain injury in the golden age of traumatic brain injury research: a Pittsburgh vision

PM Kochanek, TC Jackson, RM Jha… - Journal of …, 2020 - liebertpub.com
New neuroprotective therapies for severe traumatic brain injury (TBI) have not translated
from pre-clinical to clinical success. Numerous explanations have been suggested in both …

[HTML][HTML] CNS trauma biomarkers and surrogate endpoints pipeline from bench to bedside: a translational perspective

TH Mouhieddine, L El Houjeiri, M Sabra, RL Hayes… - 2015 - europepmc.org
A biomarker is a qualitative and quantitative biological substance or characteristic that
defines a certain pathological condition and may give indications on disease severity and …

Multi-center pre-clinical consortia to enhance translation of therapies and biomarkers for traumatic brain injury: operation brain trauma therapy and beyond

PM Kochanek, CE Dixon, S Mondello… - Frontiers in …, 2018 - frontiersin.org
Current approaches have failed to yield success in the translation of neuroprotective
therapies from the pre-clinical to the clinical arena for traumatic brain injury (TBI). Numerous …

Approach to modeling, therapy evaluation, drug selection, and biomarker assessments for a multicenter pre-clinical drug screening consortium for acute therapies in …

PM Kochanek, HM Bramlett, CE Dixon… - Journal of …, 2016 - liebertpub.com
Traumatic brain injury (TBI) was the signature injury in both the Iraq and Afghan wars and
the magnitude of its importance in the civilian setting is finally being recognized. Given the …

Biomarkers for traumatic brain injury: data standards and statistical considerations

JR Huie, S Mondello, CJ Lindsell, L Antiga… - Journal of …, 2021 - liebertpub.com
Recent biomarker innovations hold potential for transforming diagnosis, prognostic
modeling, and precision therapeutic targeting of traumatic brain injury (TBI). However, many …

The use of blood-based biomarkers to improve the design of clinical trials of traumatic brain injury

OY Glushakova, AV Glushakov, R Mannix… - Handbook of …, 2018 - Elsevier
Despite extensive research focusing on development of therapeutics for traumatic brain
injury (TBI) and success in preclinical trials, numerous phase 3 clinical trials have been …

Pre-clinical testing of therapies for traumatic brain injury

DS DeWitt, BE Hawkins, CE Dixon… - Journal of …, 2018 - liebertpub.com
Despite the large number of promising neuroprotective agents identified in experimental
traumatic brain injury (TBI) studies, none has yet shown meaningful improvements in long …

Optimizing outcome assessment in multicenter TBI trials: perspectives from TRACK-TBI and the TBI Endpoints Development Initiative

YG Bodien, M McCrea, S Dikmen… - The Journal of head …, 2018 - journals.lww.com
Traumatic brain injury (TBI) is a global public health problem that affects the long-term
cognitive, physical, and psychological health of patients, while also having a major impact …