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