Clinical trials in 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 significant 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.
Narayan
Raj K
RK
Department of Neurosurgery, Temple University Hospital, Philadelphia, Pennsylvania 19140, USA. Narayan@nimbus.temple.edu
Michel
Mary Ellen
ME
Ansell
Beth
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Baethmann
Alex
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Biegon
Anat
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Bracken
Michael B
MB
Bullock
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MR
Choi
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SC
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Guy L
GL
Contant
Charles F
CF
Coplin
William M
WM
Dietrich
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WD
Ghajar
Jamshid
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Grady
Sean M
SM
Grossman
Robert G
RG
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Edward D
ED
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William
W
Hovda
David A
DA
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Jack
J
Katz
Russell L
RL
Knoller
Nachshon
N
Kochanek
Patrick M
PM
Maas
Andrew I
AI
Majde
Jeannine
J
Marion
Donald W
DW
Marmarou
Anthony
A
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Lawrence F
LF
McIntosh
Tracy K
TK
Miller
Emmy
E
Mohberg
Noel
N
Muizelaar
J Paul
JP
Pitts
Lawrence H
LH
Quinn
Peter
P
Riesenfeld
Gad
G
Robertson
Claudia S
CS
Strauss
Kenneth I
KI
Teasdale
Graham
G
Temkin
Nancy
N
Tuma
Ronald
R
Wade
Charles
C
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Michael D
MD
Weinrich
Michael
M
Whyte
John
J
Wilberger
Jack
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AB
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D001930:Brain Injuries / Q000628:therapy*; D002986:Clinical Trials as Topic / Q000379:methods*; D006801:Humans