Sample Size Determination in Clinical Trials with Multiple Endpoints
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Beschreibung
This book integrates recent methodological developments for calculating the sample size and power in trials with more than one endpoint considered as 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 unnoticed; if the sample size is too large, it represents a waste of resources and unethically puts more participants at risk than necessary. Recently many clinical trials have been designed with more than one endpoint considered as multiple primary or co-primary, creating a need for new approaches to the design and analysis of these clinical trials. The book focuses on the evaluation of power and sample size determination when comparing the effects of two interventions in superiority clinical trials with multiple endpoints. Methods for sample size calculation in clinical trials where the alternative hypothesis is that there are effects on ALL endpoints are discussed in detail. The book also briefly examines trials designed with an alternative hypothesis of an effect on AT LEAST ONE endpoint with a prespecified non-ordering of endpoints.
This book integrates recent methodological developments for calculating the sample size and power in trials with more than one endpoint considered as 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 unnoticed; if the sample size is too large, it represents a waste of resources and unethically puts more participants at risk than necessary. Recently many clinical trials have been designed with more than one endpoint considered as multiple primary or co-primary, creating a need for new approaches to the design and analysis of these clinical trials. The book focuses on the evaluation of power and sample size determination when comparing the effects of two interventions in superiority clinical trials with multiple endpoints. Methods for sample size calculation in clinical trials where the alternative hypothesis is that there are effects on ALL endpoints are discussed in detail. The book also briefly examines trials designed with an alternative hypothesis of an effect on AT LEAST ONE endpoint with a prespecified non-ordering of endpoints.
Reviews statistical issues in clinical trials with multiple endpoints Describes methods for power and sample size calculations in clinical trials with multiple endpoints including recently developed approaches not covered in other books Includes several real clinical trial examples to illustrate the concepts and to help readers apply the methods in practice Illustrates how to implement the sample size methods using standard statistical software including SAS and R Includes supplementary material: sn.pub/extras
Autor*in
Takashi Sozu
Themen in »Sample Size Determination in Clinical Trials with Multiple Endpoints«
Binary endpoints Clinical tirals Multiple endpoints Power calculation Sample size
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“Sample Size Determination in Clinical Trials with Multiple Endpoints is a new release that will likely be embraced by any statistician involved in the planning of trials with more than one primary outcome. The book comprises much of the authors’ original work from recent years … . Sample Size Determination in Clinical Trials with Multiple Endpoints is a useful complement to the widespread … sample size books, especially for statisticians interested in designs with coprimary endpoints.” (Philip Pallmann, Biometrical Journal, Vol. 59 (1), 2017)
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