Statistical Methods for Targeted Clinical Trials under Enrichment Design
نویسندگان
چکیده
منابع مشابه
Statistical methods in clinical trials.
APPROPRIATE STATISTICAL METHODS for analysing trial data are critical for the correct interpretation of the results. Item 12 of the CONSORT statement (Box 1) relates to the statistical methods used in the reporting of trials, together with scientific and statistical principles concerning analyses of subgroups, endpoints and appropriate statistical tests. These issues need to be carefully consid...
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BACKGROUND On-site source data verification is a common and expensive activity, with little evidence that it is worthwhile. Central statistical monitoring (CSM) is a cheaper alternative, where data checks are performed by the coordinating centre, avoiding the need to visit all sites. Several publications have suggested methods for CSM; however, few have described their use in real trials. MET...
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This paper summarizes, defines, and discusses multiple endpoints comparison procedures, concepts, and methodologies for applications to clinical trials. We address the more widely used methods of alpha-level, p-value, and critical value adjustments. We examine global assessment measures such as O'Brien's test and Simes' procedure and contrast them with the alpha-adjustment procedures of Bonferr...
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Modern medicine has graduated from broad spectrum treatments to targeted therapeutics. New drugs recognize the recently discovered heterogeneity of many diseases previously considered to be fairly homogeneous. These treatments attack specific genetic pathways which are only dysregulated in some smaller subset of patients with the disease. Often this subset is only rudimentarily understood until...
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ژورنال
عنوان ژورنال: Journal of the Formosan Medical Association
سال: 2008
ISSN: 0929-6646
DOI: 10.1016/s0929-6646(09)60007-3