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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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 Abstract
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.
 Keywords
Interim analysis;bias;independent data monitoring committee;
 Language
Korean
 Cited by
 References
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