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- Title
Should data monitoring committees assess efficacy when considering safety in trials in acute stroke?
- Authors
Bath, P M W; Gray, L J; Wahlgren, N-G
- Abstract
The primary role of a trial's 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 the end of follow-up, a measure of efficacy, is also a powerful measure of safety and tested this in a systematic review.
- Publication
International journal of clinical practice, 2007, Vol 61, Issue 10, p1749
- ISSN
1368-5031
- Publication type
Journal Article
- DOI
10.1111/j.1742-1241.2007.01471.x