Should data monitoring committees assess efficacy when considering safety in trails in acute stroke?

Bath, Philip M.W. and Gray, Laura J. and Wahlgren, Nils-Gunnar (2007) Should data monitoring committees assess efficacy when considering safety in trails in acute stroke? International Journal of Clinical Practice, 61 (10). pp. 1749-1755.

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Abstract

The primary role of a trials Data Monitoring Committee (DMC) is to ensure the safety of enrolled patients. In stroke trials, safety is monitored typically by comparing death and stroke specific events between treatment groups. DMCs may also have the remit for monitoring efficacy depending on the aims of the trial. We hypothesised that functional outcome at end of follow-up, a measure of efficacy, is also a powerful measure of safety and tested this in a systematic review

Item Type: Article
Uncontrolled Keywords: stroke; clinical trial; data monitoring committees; functional outcome; efficacy; impairment
Schools/Departments: University of Nottingham UK Campus > Faculty of Medicine and Health Sciences > School of Medicine > Division of Clinical Neuroscience
Depositing User: Sayers, Hazel
Date Deposited: 19 Sep 2007
Last Modified: 14 Aug 2013 13:44
URI: http://eprints.nottingham.ac.uk/id/eprint/544

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