@article{ref1,
title="Evaluation of designs for clinical trials of neuroprotective agents in head injury. European Brain Injury Consortium",
journal="Journal of neurotrauma",
year="1999",
author="Machado, S. G. and Murray, G. D. and Teasdale, G. M.",
volume="16",
number="12",
pages="1131-1138",
abstract="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 &quot;neuroprotective&quot; 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>",
language="en",
issn="0897-7151",
doi="",
url="http://dx.doi.org/"
}