A critical assessment of composite and coprimary endpoints: A complex problem

Randomized, placebo-controlled trials have for decades been the gold standard in evaluating new medical interventions; however, the determination of efficacy is highly dependent on the selection of the primary endpoint. While this may initially seem straightforward, choosing a primary endpoint can be complex, and may ultimately lead to the apparent success or failure of the intervention. With our growing understanding of disease complexity and the increasing number of diagnostic technologies available, investigators have increasingly turned to multiple-measure endpoints to satisfy the different ways in which we measure disease and its burden on patients.