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The Necessity of Independent Data Monitoring Committee in Domestic Clinical Trials
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 Title & Authors
The Necessity of Independent Data Monitoring Committee in Domestic Clinical Trials
Kang, Seung-Ho;
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In adaptive designs important components of clinical trials may be changed based on the results of interim analysis. Several international guidelines point out that such interim analysis should be performed by independent experts who do not participate in clinical trials when adaptive designs are used in therapeutic confirmatory clinical trials, and if not, it may cause bias. The international guidelines recommend the establishment of independent data monitoring committee for conducting interim analysis independently.
Interim analysis;bias;independent data monitoring committee;
 Cited by
Chang, M. (2008). Adaptive Design Theory and Implementation Using SAS and R, Chapman & Hall/CRC, New York

CHMP (2005). Guideline on Data Monitoring Committees

CHMP (2006). Reflection paper on methodological issues in confirmatory clinical trials with planned with an adaptive design

Chow, S. C. and Chang, M. (2007). Adaptive Design Methods in Clinical Trials, Chapman & Hall/CRC, New York

Ellenberg, S. S., Fleming, T. R. and DeMets, D. L. (2002). Data Monitoring Committees in Clinical Trials:A Practical Perspective, John Wiley & Sons, New York

ICH E6 (1996). International Conference on Harmonization Tripartite Guideline for Good Clinical Practice

ICH E9 (1998). Note for Guidance on Statistical Principles for Clinical Trials

Wang, S. J. and Hung, J. (2008). Adaptive Designs in Drug Development, ISBS short course note