What happens -- and should happen -- when a clinical trial fails to meet its primary endpoint? That's the topic addressed in a . What often happens is argument over whether negative primary endpoint results should be ignored in favor of secondary outcomes. What should happen, the authors suggest, is designing studies well enough in the first place that their outcomes don't invite competing interpretations.
In this 150-second video analysis, ڴŮ clinical reviewer F. Perry Wilson takes a closer look at two points raised in the review: the interpretation of P values that determine whether a trial outcome is negative or positive, and when it's appropriate to look to secondary outcomes.
, is an assistant professor of medicine at the Yale School of Medicine. He earned his BA from Harvard University, graduating with honors with a degree in biochemistry. He then attended Columbia College of Physicians and Surgeons in New York City. From there he moved to Philadelphia to complete his internal medicine residency and nephrology fellowship at the Hospital of the University of Pennsylvania. During his post graduate years, he also obtained a Master of Science in Clinical Epidemiology from the University of Pennsylvania. He is an accomplished author of many scientific articles and holds several NIH grants. He is a ڴŮ reviewer, and in addition to his video analyses, he authors a blog, . You can follow .
Primary Source
New England Journal of Medicine
Pocock S and Stone G "The Primary Outcome Fails -- What Next?" N Engl J Med 2016; DOI: 10.1056/NEJMra1510064.