Clinical Trials in Head Injury

RAJ K NARAYAN; MARY ELLEN MICHEL; Beth Ansell; Alex Baethmann; Anat Biegon; Michael B Bracken; M. Ross Bullock; Sung C Choi; Guy L Clifton; Charles F Contant; William M Coplin; W. Dalton Dietrich; Jamshid Ghajar; Sean M Grady; Robert G Grossman; Edward D Hall; William Heetderks; David A Hovda; Jack Jallo; Russell L Katz; Nachshon Knoller; Patrick M Kochanek; Andrew I Maas; Jeannine Majde; Donald W Marion; Anthony Marmarou; Lawrence F Marshall; Tracy K McIntosh; Emmy Miller; Noel Mohberg; J. Paul Muizelaar; Lawrence H Pitts; Peter Quinn; Gad Riesenfeld; Claudia S Robertson; Kenneth I Strauss; Graham Teasdale; Nancy Temkin; Ronald Tuma; Charles Wade; Michael D Walker; Michael Weinrich; John Whyte; Jack Wilberger; A. Byron Young; Lorraine Yurkewicz

doi:10.1089/089771502753754037

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Journal article

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Peer reviewed

Clinical Trials in Head Injury

RAJ K NARAYAN, MARY ELLEN MICHEL, Beth Ansell, Alex Baethmann, Anat Biegon, Michael B Bracken, M. Ross Bullock, Sung C Choi, Guy L Clifton, Charles F Contant, …

Journal of neurotrauma, Vol.19(5), pp.503-557

2002-05

DOI: https://doi.org/10.1089/089771502753754037

PMCID: PMC1462953

PMID: 12042091

Abstract

intracranial pressure

uniformed consent

outcome measures

traumatic brain injury

clinical trials

trial design

head injury

Traumatic brain injury (TBI) remains a major public health problem globally. In the United States the incidence of closed head injuries admitted to hospitals is conservatively estimated to be 200 per 100,000 population, and the incidence of penetrating head injury is estimated to be 12 per 100,000, the highest of any developed country in the world. This yields an approximate number of 500,000 new cases each year, a sizeable proportion of which demonstrate signficant long-term disabilities. Unfortunately, there is a paucity of proven therapies for this disease. For a variety of reasons, clinical trials for this condition have been difficult to design and perform. Despite promising pre-clinical data, most of the trials that have been performed in recent years have failed to demonstrate any significant improvement in outcomes. The reasons for these failures have not always been apparent and any insights gained were not always shared. It was therefore feared that we were running the risk of repeating our mistakes. Recognizing the importance of TBI, the National Institute of Neurological Disorders and Stroke (NINDS) sponsored a workshop that brought together experts from clinical, research, and pharmaceutical backgrounds. This workshop proved to be very informative and yielded many insights into previous and future TBI trials. This paper is an attempt to summarize the key points made at the workshop. It is hoped that these lessons will enhance the planning and design of future efforts in this important field of research.

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Collaboration types: Industry collaboration; Domestic collaboration; International collaboration
Citation topics: 1 Clinical & Life Sciences; 1.134 Trauma & Emergency Surgery; 1.134.286 Traumatic Brain Injury
Web Of Science research areas: Clinical Neurology; Critical Care Medicine; Neurosciences
ESI research areas: Neuroscience & Behavior

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Title: Clinical Trials in Head Injury
Creators: RAJ K NARAYAN - Department of Neurosurgery, Temple University Hospital, Philadelphia, Pennsylvania
MARY ELLEN MICHEL - National Institute of Neurological Disorders and Stroke, Bethesda, Maryland
Beth Ansell - NIH/NCMRR, Bethesda, Maryland
Alex Baethmann - Ludwig-Maximilians University of Munich, Munich, Germany
Anat Biegon - Lawrence Berkeley National Laboratory, Berkeley, California
Michael B Bracken - Yale University School of Medicine, New Haven, Connecticut
M. Ross Bullock - Virginia Commonwealth University, Richmond, Virginia
Sung C Choi - Virginia Commonwealth University, Richmond, Virginia
Guy L Clifton - University of Texas HSC, Houston, Texas
Charles F Contant - Baylor College of Medicine, Houston, Texas
William M Coplin - Wayne State University School of Medicine, Detroit, Michigan
W. Dalton Dietrich - University of Miami School of Medicine, Miami, Florida
Jamshid Ghajar - Brain Trauma Foundation, New York, New York
Sean M Grady - Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
Robert G Grossman - Baylor College of Medicine, Houston, Texas
Edward D Hall - Pfizer Global R&D, Ann Arbor, Michigan
William Heetderks - NIH/NINDS, Bethesda, Maryland
David A Hovda - University of California, Los Angeles, California
Jack Jallo - Temple University School of Medicine, Philadelphia, Pennsylvania
Russell L Katz - Food and Drug Administration, Rockville, Maryland
Nachshon Knoller - Sheba Medical Center, Tel-Hashomer, Israel
Patrick M Kochanek - University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
Andrew I Maas - Academic Hospital, Rotterdam, The Netherlands
Jeannine Majde - Office of Naval Research, Arlington, Virginia
Donald W Marion - University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
Anthony Marmarou - Virginia Commonwealth University, Richmond, Virginia
Lawrence F Marshall - University of California, San Diego, La Jolla, California
Tracy K McIntosh - Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
Emmy Miller - University of Texas HSC, Houston, Texas
Noel Mohberg - Parke-Davis Pharmaceutical Research, Ann Arbor, Michigan
J. Paul Muizelaar - University of California at Davis Medical Center, Sacramento, California
Lawrence H Pitts - University of California, San Francisco, California
Peter Quinn - Brain Trauma Foundation, New York, New York
Gad Riesenfeld - Pharmos Corporation, Iselin, New Jersey
Claudia S Robertson - Baylor College of Medicine, Houston, Texas
Kenneth I Strauss - Temple University School of Medicine, Philadelphia, Pennsylvania
Graham Teasdale - Southern General Hospital, Glasgow, Scotland
Nancy Temkin - University of Washington, Seattle, Washington
Ronald Tuma - Temple University School of Medicine, Philadelphia, Pennsylvania
Charles Wade - Sausalito, California
Michael D Walker - NIH/NINDS, Bethesda, Maryland
Michael Weinrich - NIH/NCMRR, Bethesda, Maryland
John Whyte - Temple University School of Medicine, Philadelphia, Pennsylvania
Jack Wilberger - Allegheny General Hospital, Pittsburgh, Pennsylvania
A. Byron Young - University of Kentucky Chandler Medical Center, Lexington, Kentucky
Lorraine Yurkewicz - Pfizer Pharmaceuticals, Groton, Connecticut
Publication Details: Journal of neurotrauma, Vol.19(5), pp.503-557
Academic Unit: Leadership Department; Miller School of Medicine; Miami Project to Cure Paralysis; UMMG Dept of Neurological Surgery
Language: English
Resource Type: Journal article
PMID: 12042091
PMCID: PMC1462953
Record Identifier: 991031560340402976