Design and statistical issues in multicenter trials of severe head injury

被引:17
作者
Choi, SC [1 ]
Bullock, R [1 ]
机构
[1] Virginia Commonwealth Univ, Med Coll Virginia, Richmond, VA 23298 USA
关键词
head injury; randomised clinical trials; Glasgow coma scale; therapy;
D O I
10.1179/016164101101198325
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
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.
引用
收藏
页码:190 / 192
页数:3
相关论文
共 8 条
[1]  
BRACKEN MB, 2001, IN PRESS NEUROSURGER
[2]  
Choi S C, 1998, J Biopharm Stat, V8, P367, DOI 10.1080/10543409808835246
[3]   Primary end points in phase III clinical trials of severe head trauma: DRS versus GOS [J].
Choi, SC ;
Marmarou, A ;
Bullock, R ;
Nichols, JS ;
Wei, X ;
Pitts, LH .
JOURNAL OF NEUROTRAUMA, 1998, 15 (10) :771-776
[4]   Clinical neuro-protection trials in severe traumatic brain injury: Lessons from previous studies [J].
Doppenberg, EMR ;
Bullock, R .
JOURNAL OF NEUROTRAUMA, 1997, 14 (02) :71-80
[5]  
EDERER P, 1975, AM J EPIDEMIOL, V102, P111
[6]   MULTIPLE TESTING PROCEDURE FOR CLINICAL-TRIALS [J].
OBRIEN, PC ;
FLEMING, TR .
BIOMETRICS, 1979, 35 (03) :549-556
[7]   QUALITY OF INSTITUTIONAL PARTICIPATION IN MULTI-CENTER CLINICAL-TRIALS [J].
SYLVESTER, RJ ;
PINEDO, HM ;
DEPAUW, M ;
STAQUET, MJ ;
BUYSE, ME ;
RENARD, J ;
BONADONNA, G .
NEW ENGLAND JOURNAL OF MEDICINE, 1981, 305 (15) :852-855
[8]   GROUP SEQUENTIAL CLINICAL-TRIALS WITH TRIANGULAR CONTINUATION REGIONS [J].
WHITEHEAD, J ;
STRATTON, I .
BIOMETRICS, 1983, 39 (01) :227-236