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Strength of accumulating evidence and data monitoring committee decision making
Author(s) -
George Stephen L.,
Freidlin Boris,
Korn Edward L.
Publication year - 2004
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.1859
Subject(s) - data monitoring committee , clinical trial , computer science , clinical decision making , component (thermodynamics) , operations research , psychology , medicine , intensive care medicine , engineering , pathology , physics , thermodynamics
The data monitoring committee (DMC) is a vital component of a randomized clinical trial. Its responsibilities include stopping the trial early for extreme results. The decision to stop the trial must be based on a careful synthesis of statistical methodology and clinical judgment. It is critical to ensure the validity of this complex process. In this paper we present results of a survey of 21 DMC members conducted to investigate how they evaluate accumulating evidence. The results indicate that some DMC members may be over‐interpreting developing trends in the data. Copyright © 2004 John Wiley & Sons, Ltd.