Sample Size Considerations in Clinical Trials when Comparing Two Interventions using Multiple Co-Primary Binary Relative Risk Contrasts.

ABSTRACT: The effects of interventions are multi-dimensional. Use of more than one primary endpoint offers an attractive design feature in clinical trials as they capture more complete characterization of the effects of an intervention and provide more informative intervention comparisons. For these reasons, multiple primary endpoints have become a common design feature in many disease areas such as oncology, infectious disease, and cardiovascular disease. More specifically in medical product development, multiple endpoints are utilized as co-primary to evaluate the effect of the new interventions. Although methodologies to address continuous co-primary endpoints are well-developed, methodologies for binary endpoints are limited. In this paper, we describe power and sample size determination for cli

SUBMITTER: Ando Y 

PROVIDER: S-EPMC4497828 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature