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

Bath, Philip M.W.; Gray, Laura J.; Wahlgren, Nils-Gunnar

Authors

Philip M.W. Bath

Laura J. Gray

Nils-Gunnar Wahlgren



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

Journal Article Type Article
Publication Date Oct 1, 2007
Journal International Journal of Clinical Practice
Print ISSN 1368-5031
Publisher Wiley
Peer Reviewed Peer Reviewed
Volume 61
Issue 10
APA6 Citation Bath, P. M., Gray, L. J., & Wahlgren, N. (2007). Should data monitoring committees assess efficacy when considering safety in trails in acute stroke?. International Journal of Clinical Practice, 61(10),
Keywords stroke; clinical trial; data monitoring committees; functional outcome; efficacy; impairment
Copyright Statement Copyright information regarding this work can be found at the following address: http://eprints.nottingh.../end_user_agreement.pdf

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Copyright Statement
Copyright information regarding this work can be found at the following address: http://eprints.nottingham.ac.uk/end_user_agreement.pdf





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