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Titolo:
Evaluation of designs for clinical trials of neuroprotective agents in head injury
Autore:
Machado, SG; Murray, GD; Teasdale, GM;
Indirizzi:
Univ Edinburgh, Sch Med, Edinburgh EH8 9AG, Midlothian, Scotland Univ Edinburgh Edinburgh Midlothian Scotland EH8 9AG Midlothian, Scotland US FDA, Off Biostat, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA US FDA Rockville MD USA 20857 Drug Evaluat & Res, Rockville, MD 20857 USA Univ Glasgow, Dept Neurosurg, Inst Neurol Sci, So Gen Hosp, Glasgow, Lanark, Scotland Univ Glasgow Glasgow Lanark Scotland Gen Hosp, Glasgow, Lanark, Scotland
Titolo Testata:
JOURNAL OF NEUROTRAUMA
fascicolo: 12, volume: 16, anno: 1999,
pagine: 1131 - 1138
SICI:
0897-7151(199912)16:12<1131:EODFCT>2.0.ZU;2-Y
Fonte:
ISI
Lingua:
ENG
Soggetto:
MULTICENTER; NIMODIPINE; EFFICACY; SEPSIS;
Keywords:
clinical trial design; head injury; prognostic models; statistical power;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Life Sciences
Citazioni:
15
Recensione:
Indirizzi per estratti:
Indirizzo: Murray, GD Univ Edinburgh, Sch Med, Teviot Pl, Edinburgh EH8 9AG, Midlothian, Scotland Univ Edinburgh Teviot Pl Edinburgh Midlothian Scotland EH8 9AG
Citazione:
S.G. Machado et al., "Evaluation of designs for clinical trials of neuroprotective agents in head injury", J NEUROTRAU, 16(12), 1999, pp. 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 "neuroprotective" treatment on outcome, and their interaction with a range ofstrategies 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.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 28/11/20 alle ore 21:47:21