Clinical trials in head injury

Raj K. Narayan, 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, Mary Ellen Michel, Russell L. Katz, Nachshon Knoller, Patrick M. Kochanek, Andrew I. Maas, Jeannine Majde, Donald W. Marion, Anthony Marmarou, Lawrence F. MarshallTracy K. McIntosh, Emmy Miller, Beth Ansell, Noel Mohberg, J. Paul Muizelaar, Lawrence H. Pitts, Peter Quinn, Gad Riesenfeld, Claudia S. Robertson, Kenneth I. Strauss, Jan Paul Muizelaar, Nancy Temkin, Ronald Tuma, Alex Baethmann, Charles Wade, Michael D. Walker, Michael Weinrich, John Whyte, Jack Wilberger, A. Byron Young, Lorraine Yurkewicz, Anat Biegon, Michael B. Bracken, M. Ross Bullock, Sung C. Choi, Guy L. Clifton

Research output: Contribution to journalArticle

647 Citations (Scopus)

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 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.

Original languageEnglish (US)
Pages (from-to)503-557
Number of pages55
JournalJournal of Neurotrauma
Volume19
Issue number5
StatePublished - 2002

Fingerprint

Craniocerebral Trauma
Clinical Trials
Education
Penetrating Head Injuries
National Institute of Neurological Disorders and Stroke
Closed Head Injuries
Incidence
Developed Countries
Public Health
Research
Population
Traumatic Brain Injury
Therapeutics

Keywords

  • Clinical trials
  • Head injury
  • Intracranial pressure
  • Outcome measures
  • Traumatic brain injury
  • Trial design
  • Uniformed consent

ASJC Scopus subject areas

  • Clinical Neurology
  • Neuroscience(all)

Cite this

Narayan, R. K., Contant, C. F., Coplin, W. M., Dietrich, W. D., Ghajar, J., Grady, S. M., ... Clifton, G. L. (2002). Clinical trials in head injury. Journal of Neurotrauma, 19(5), 503-557.

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

In: Journal of Neurotrauma, Vol. 19, No. 5, 2002, p. 503-557.

Research output: Contribution to journalArticle

Narayan, RK, Contant, CF, Coplin, WM, Dietrich, WD, Ghajar, J, Grady, SM, Grossman, RG, Hall, ED, Heetderks, W, Hovda, DA, Jallo, J, Michel, ME, Katz, RL, Knoller, N, Kochanek, PM, Maas, AI, Majde, J, Marion, DW, Marmarou, A, Marshall, LF, McIntosh, TK, Miller, E, Ansell, B, Mohberg, N, Muizelaar, JP, Pitts, LH, Quinn, P, Riesenfeld, G, Robertson, CS, Strauss, KI, Muizelaar, JP, Temkin, N, Tuma, R, Baethmann, A, Wade, C, Walker, MD, Weinrich, M, Whyte, J, Wilberger, J, Young, AB, Yurkewicz, L, Biegon, A, Bracken, MB, Bullock, MR, Choi, SC & Clifton, GL 2002, 'Clinical trials in head injury', Journal of Neurotrauma, vol. 19, no. 5, pp. 503-557.
Narayan RK, Contant CF, Coplin WM, Dietrich WD, Ghajar J, Grady SM et al. Clinical trials in head injury. Journal of Neurotrauma. 2002;19(5):503-557.
Narayan, Raj K. ; Contant, Charles F. ; Coplin, William M. ; Dietrich, W. Dalton ; Ghajar, Jamshid ; Grady, Sean M. ; Grossman, Robert G. ; Hall, Edward D. ; Heetderks, William ; Hovda, David A. ; Jallo, Jack ; Michel, Mary Ellen ; Katz, Russell L. ; Knoller, Nachshon ; Kochanek, Patrick M. ; Maas, Andrew I. ; Majde, Jeannine ; Marion, Donald W. ; Marmarou, Anthony ; Marshall, Lawrence F. ; McIntosh, Tracy K. ; Miller, Emmy ; Ansell, Beth ; Mohberg, Noel ; Muizelaar, J. Paul ; Pitts, Lawrence H. ; Quinn, Peter ; Riesenfeld, Gad ; Robertson, Claudia S. ; Strauss, Kenneth I. ; Muizelaar, Jan Paul ; Temkin, Nancy ; Tuma, Ronald ; Baethmann, Alex ; Wade, Charles ; Walker, Michael D. ; Weinrich, Michael ; Whyte, John ; Wilberger, Jack ; Young, A. Byron ; Yurkewicz, Lorraine ; Biegon, Anat ; Bracken, Michael B. ; Bullock, M. Ross ; Choi, Sung C. ; Clifton, Guy L. / Clinical trials in head injury. In: Journal of Neurotrauma. 2002 ; Vol. 19, No. 5. pp. 503-557.
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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 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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AU - Contant, Charles F.

AU - Coplin, William M.

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AU - Ghajar, Jamshid

AU - Grady, Sean M.

AU - Grossman, Robert G.

AU - Hall, Edward D.

AU - Heetderks, William

AU - Hovda, David A.

AU - Jallo, Jack

AU - Michel, Mary Ellen

AU - Katz, Russell L.

AU - Knoller, Nachshon

AU - Kochanek, Patrick M.

AU - Maas, Andrew I.

AU - Majde, Jeannine

AU - Marion, Donald W.

AU - Marmarou, Anthony

AU - Marshall, Lawrence F.

AU - McIntosh, Tracy K.

AU - Miller, Emmy

AU - Ansell, Beth

AU - Mohberg, Noel

AU - Muizelaar, J. Paul

AU - Pitts, Lawrence H.

AU - Quinn, Peter

AU - Riesenfeld, Gad

AU - Robertson, Claudia S.

AU - Strauss, Kenneth I.

AU - Muizelaar, Jan Paul

AU - Temkin, Nancy

AU - Tuma, Ronald

AU - Baethmann, Alex

AU - Wade, Charles

AU - Walker, Michael D.

AU - Weinrich, Michael

AU - Whyte, John

AU - Wilberger, Jack

AU - Young, A. Byron

AU - Yurkewicz, Lorraine

AU - Biegon, Anat

AU - Bracken, Michael B.

AU - Bullock, M. Ross

AU - Choi, Sung C.

AU - Clifton, Guy L.

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