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Composite Primary Outcomes in Nephrology Clinical Trials
Steven Fishbane1, Pratap Upadrista1, Hitesh H Shah1
1Division of Kidney Diseases and Hypertension, Northwell Health, Zucker School of Medicine, Great Neck, NY.
Abstract:
Composite study endpoints have made it possible to reduce the sample size and lower the cost of certain clinical trials. In nephrology trials, the use of composite endpoints has led to opportunities but has also created challenges in the interpretation of study results. In this perspective, we review how composite outcomes work and why there are risks attendant to their use. We also provide examples of the use of composite outcomes from specific nephrology trials and certain problems that resulted.
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