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Strength of accumulating evidence and data monitoring committee decision making
Stephen L George1, Boris Freidlin, Edward L Korn
1Department of Biostatistics and Bioinformatics, Box 3958, Duke University Medical Center, Durham, NC 27710, USA. stephen.george@duke.edu
Abstract:
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.
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