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The use of data monitoring committees in Canadian trial groups.

作者信息

Pater J L

机构信息

NCIC Clinical Trials Group, Queen's University, Kingston, Ontario, Canada.

出版信息

Stat Med. 1993 Mar;12(5-6):505-8. doi: 10.1002/sim.4780120516.

DOI:10.1002/sim.4780120516
PMID:8493428
Abstract

Following a brief overview of the funding and structure of clinical trials research in Canada, experience with data monitoring committees (DMCs) in four clinical trials organizations is reviewed. Whether committees are required, their mode of selection, composition, degree of independence, mandate and reporting relationships have varied substantially among the groups. Overall the Canadian experience with DMCs has been representative, although formalization of the role of these committees has not proceeded as far as it has in some US agencies.

摘要

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