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

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 aim...

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Main Authors: Bath, Philip M.W., Gray, Laura J., Wahlgren, Nils-Gunnar
Format: Article
Published: Blackwell Publishing 2007
Subjects:
Online Access:https://eprints.nottingham.ac.uk/544/
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author Bath, Philip M.W.
Gray, Laura J.
Wahlgren, Nils-Gunnar
author_facet Bath, Philip M.W.
Gray, Laura J.
Wahlgren, Nils-Gunnar
author_sort Bath, Philip M.W.
building Nottingham Research Data Repository
collection Online Access
description 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
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publishDate 2007
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spelling nottingham-5442020-05-04T20:28:06Z https://eprints.nottingham.ac.uk/544/ Should data monitoring committees assess efficacy when considering safety in trails in acute stroke? Bath, Philip M.W. Gray, Laura J. Wahlgren, Nils-Gunnar 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 Blackwell Publishing 2007-10 Article PeerReviewed Bath, Philip M.W., 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. stroke; clinical trial; data monitoring committees; functional outcome; efficacy; impairment
spellingShingle stroke; clinical trial; data monitoring committees; functional outcome; efficacy; impairment
Bath, Philip M.W.
Gray, Laura J.
Wahlgren, Nils-Gunnar
Should data monitoring committees assess efficacy when considering safety in trails in acute stroke?
title Should data monitoring committees assess efficacy when considering safety in trails in acute stroke?
title_full Should data monitoring committees assess efficacy when considering safety in trails in acute stroke?
title_fullStr Should data monitoring committees assess efficacy when considering safety in trails in acute stroke?
title_full_unstemmed Should data monitoring committees assess efficacy when considering safety in trails in acute stroke?
title_short Should data monitoring committees assess efficacy when considering safety in trails in acute stroke?
title_sort should data monitoring committees assess efficacy when considering safety in trails in acute stroke?
topic stroke; clinical trial; data monitoring committees; functional outcome; efficacy; impairment
url https://eprints.nottingham.ac.uk/544/