Evidence map›Paper›PMID 28363253›Full record

ArticleJournal of neurotrauma2017

The Traumatic Brain Injury Endpoints Development (TED) Initiative: Progress on a Public-Private Regulatory Collaboration To Accelerate Diagnosis and Treatment of Traumatic Brain Injury.

Geoffrey T Manley, Christine L Mac Donald, Amy J Markowitz, Diane Stephenson, Ann Robbins, Raquel C Gardner, Ethan Winkler, Yelena G Bodien, Sabrina R Taylor, John K Yue and 5 more

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of neurotrauma, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 3 pooled it
5.5field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 3 syntheses or guidelines pooled it, 55 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Article
  9. Covert consciousness.NeuroRehabilitation · 2024
    Article
  10. Transforming Drug Development for Neurological Disorders: Proceedings from a Multidisease Area Workshop.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2023
    Article
  11. Article
  12. Article
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  14. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 5 institutions in 1 country.

Geoffrey T ManleyDepartment 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.
Christine L Mac DonaldDepartment of Neurological Surgery, University of Washington, Seattle, Washington.
Amy J MarkowitzDepartment 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.
Diane StephensonCritical Path Institute, Tucson, Arizona.
Ann RobbinsCritical Path Institute, Tucson, Arizona.
Raquel C GardnerDepartment of Neurology, University of California San Francisco, San Francisco, California.
Ethan WinklerDepartment of Neurological Surgery, University of California San Francisco, San Francisco, California.
Yelena G BodienDepartment of Physical Medicine and Rehabilitation, Harvard Medical School, Charlestown, Massachusetts.
Sabrina R TaylorDepartment 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.
John K YueDepartment 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.
Lakshmi KannanEmergency Preparedness/Operations and Medical Countermeasures Program, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
Allison KumarIndependent consultant.
Michael A McCreaDepartment of Neurosurgery, Medical College of Wisconsin, Milwaukee, Wisconsin.
Kevin K WangProgram for Neurotrauma, Neuroproteomics & Biomarker Research, Department of Psychiatry, McKnight Brain Institute, University of Florida, Gainesville, Florida.
TED Investigators
Critical Path Institute · USNeurological Surgery · USHarvard University · USMedical College of Wisconsin · USUniversity of California, San Francisco · US

Funding

Transforming Research and Clinical Knowledge in Traumatic Brain InjuryU01NS086090 · NINDS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI DIAZ-ARRASTIA, RAMON, GIACINO, JOSEPH THOMAS · 2013 to 2017
$19.1M
Traumatic Brain Injury and The Aging Brain: Predictors of Clinical TrajectoriesK23NS095755 · NINDS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GARDNER, RAQUEL C. · 2015 to 2019
$872k
NINDS NIH HHS K23 NS095755NINDS NIH HHS U01 NS086090
6 · The paper itself

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.

Indexed as

biomarkersclinical outcome measuresCTFDAMRItraumatic brain injury

Identifiers

PMID28363253
PMCPMC5647488
OpenAlexW2597928394

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.