TY  - JOUR
PY  - 1999//
TI  - Evaluation of designs for clinical trials of neuroprotective agents in head injury. European Brain Injury Consortium
JO  - Journal of neurotrauma
A1  - Machado, S. G.
A1  - Murray, G. D.
A1  - Teasdale, G. M.
SP  - 1131
EP  - 1138
VL  - 16
IS  - 12
N2  - In a study involving the statistical modeling of potential head injury trials, we explore approaches to trial design that could enhance their power to detect treatment-related effects on clinical outcome. The study uses a survey organized by the European Brain Injury Consortium of over 1,000 head-injured patients to characterize the population from which trial participants can be selected. A variety of models are postulated for the effects of "neuroprotective" treatment on outcome, and their interaction with a range of strategies for targeting patients for inclusion in the trial is evaluated. A very simple strategy of targeting patients with an intermediate prognosis was found to allow a reduction in sample size by 30%, with no reduction in statistical power. This paper illustrates an important methodology for studying the characteristics of competing trial designs.<p /> <p>Language: en</p>
LA  - en
SN  - 0897-7151
UR  - http://dx.doi.org/
ID  - ref1
ER  -