Abstract
Multicenter clinical trials are the most powerful agent to evaluate new therapies in medicine, but have failed to impact traumatic brain injury, in which at least 20 such trials have been performed, without a positive result. Such trials need to be carefully planned, with a run-in period to ensure center compliance. Stratification, careful monitoring, adequate sample size, interim analysis and adequate numbers of patients per center are all vital requirements for a useful outcome in such trials.
| Original language | English |
|---|---|
| Pages (from-to) | 190-192 |
| Number of pages | 3 |
| Journal | Neurological Research |
| Volume | 23 |
| Issue number | 2-3 |
| DOIs | |
| State | Published - Apr 23 2001 |
| Externally published | Yes |
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Keywords
- Glasgow Coma Scale
- Head injury
- Randomised clinical trials
- Therapy
ASJC Scopus subject areas
- Clinical Neurology
- Neuroscience(all)
Cite this
Design and statistical issues in multicenter trials of severe head injury. / Choi, S. C.; Bullock, Ross.
In: Neurological Research, Vol. 23, No. 2-3, 23.04.2001, p. 190-192.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Design and statistical issues in multicenter trials of severe head injury
AU - Choi, S. C.
AU - Bullock, Ross
PY - 2001/4/23
Y1 - 2001/4/23
N2 - Multicenter clinical trials are the most powerful agent to evaluate new therapies in medicine, but have failed to impact traumatic brain injury, in which at least 20 such trials have been performed, without a positive result. Such trials need to be carefully planned, with a run-in period to ensure center compliance. Stratification, careful monitoring, adequate sample size, interim analysis and adequate numbers of patients per center are all vital requirements for a useful outcome in such trials.
AB - Multicenter clinical trials are the most powerful agent to evaluate new therapies in medicine, but have failed to impact traumatic brain injury, in which at least 20 such trials have been performed, without a positive result. Such trials need to be carefully planned, with a run-in period to ensure center compliance. Stratification, careful monitoring, adequate sample size, interim analysis and adequate numbers of patients per center are all vital requirements for a useful outcome in such trials.
KW - Glasgow Coma Scale
KW - Head injury
KW - Randomised clinical trials
KW - Therapy
UR - http://www.scopus.com/inward/record.url?scp=0035074348&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0035074348&partnerID=8YFLogxK
U2 - 10.1179/016164101101198325
DO - 10.1179/016164101101198325
M3 - Article
C2 - 11320598
AN - SCOPUS:0035074348
VL - 23
SP - 190
EP - 192
JO - Neurological Research
JF - Neurological Research
SN - 0161-6412
IS - 2-3
ER -