Design and statistical issues in multicenter trials of severe head injury

S. C. Choi, R. Bullock

Research output: Contribution to journalArticle

18 Scopus citations

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 languageEnglish (US)
Pages (from-to)190-192
Number of pages3
JournalNeurological Research
Volume23
Issue number2-3
DOIs
StatePublished - Apr 23 2001

Keywords

  • Glasgow Coma Scale
  • Head injury
  • Randomised clinical trials
  • Therapy

ASJC Scopus subject areas

  • Clinical Neurology
  • Neuroscience(all)

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