EAN: 9783319220048

SPRINGERBRIEFS IN STATISTICS SAMPLE SIZE DETE...

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 brie y examines trials designed with an
alternative hypothesis of an effect on AT LEAST ONE endpoint with a prespecified non-ordering
of endpoints.

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