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Titlebook: Sample Size Determination in Clinical Trials with Multiple Endpoints; Takashi Sozu,Tomoyuki Sugimoto,Scott R. Evans Book 2015 The Author(s

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Convenient Sample Size Formula,ple size formula with associated numerical tables for sizing clinical trials with multiple co-primary endpoints. We provide numerical examples to illustrate use of the formula and associated tables, and provide the programming codes for the R and SAS software packages.
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Further Developments,elopments for designing randomized trials with other design characteristics including: (i) other inferential goals, (ii) more than two intervention groups, (iii) group sequential designs, and (iv) endpoints with other measurement scales such as time to-event.
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Binary Co-primary Endpoints,l method with and without a continuity correction, the arcsine method with and without a continuity correction, and the Fisher’s exact method. We evaluate the behavior of the sample size and empirical power associated with the methods. We also provide numerical examples to illustrate the methods.
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Book 2015 multiple primary or co-primary, offering an important reference work for statisticians working in this area..The determination of sample size and the evaluation of power are fundamental and critical elements in the design of clinical trials. If the sample size is too small, important effects may go
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Introduction,apture a more complete characterization of the intervention effects and provide more informative intervention comparisons. For these reasons, use of more than one primary endpoint has become a common design feature in clinical trials for disease areas such as oncology, infectious disease, and cardio
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Continuous Co-primary Endpoints,interventions with multiple co-primary continuous endpoints in a clinical trial. We provide numerical examples to illustrate the methods and introduce conservative sample sizing strategies for these clinical trials.
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