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Independent data monitoring committees: rationale, operations and controversies
Author(s) -
Ellenberg Susan S.
Publication year - 2001
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.730
Subject(s) - variety (cybernetics) , data monitoring committee , process (computing) , computer science , clinical trial , process management , operations research , medicine , risk analysis (engineering) , management science , business , economics , engineering , pathology , artificial intelligence , operating system
Data monitoring committees (DMCs) have become an increasingly common component of randomized clinical trials in recent years. As experience has accumulated, and more individuals and organizations have become involved in such activities, a variety of approaches to the operation of such committees has inevitably arisen. Because these committees play such a critical role in the process of new drug development, it is important to consider the implications of the different approaches that are being used. It is also timely to consider the present and possible future regulatory status of data monitoring committees. Published in 2001 by John Wiley & Sons, Ltd.