Data Monitoring Safety Board
President of the World Stroke Organization
Prof. Geoffrey A. Donnan, MD is a Professor of Neurology, University of Melbourne and Director of the National Stroke Research Institute in Australia. He was a co-founder of the Australian Stroke Trial Network which conducts numerous stroke trials. He has authored over 300 peer reviewed journal publications, 51 books chapters and edited 15 proceedings of national meetings. He has also written and edited 3 books and had sat on the editorial boards of 7 international journals including Lancet, Neurology, stroke and Cerebrovascular Diseases.
Dr Christophe Tzourio
Hopital La Pitie Salpetriere, Paris, France
Prof. David Machin
CTERU, Singapore
First Data Safety Monitoring Board Meeting was held on 25th of October 2009
- Reviewed baseline and follow up data from 1st 220 patients
- No Safety concerns
- High data quality
- Strongly recommended continuation of recruitment
Second Data Safety Monitoring Board Meeting was held on 28th of March 2011
- Reviewed safety and outcome on 659patients
- Safety data alone was also available for total of 743 patients
- No safety concerns
- Recommended to continue recruitment to the full sample size of 1100 patients
Advised:
- Recruitment of patients with more severe stroke
- Reduction of loss to follow up rates