Regulatory Approval and Practice Guidelines Involving Cardiovascular Valve Devices: Determining the Right Evidentiary Bar.
Sign Up to like & getrecommendations! Published in 2020 at "Journal of the American College of Cardiology"
DOI: 10.1016/j.jacc.2020.06.057
Abstract: Randomized clinical trials (RCTs) are one of the foundations of evidence generation to determine the safety and effectiveness of new therapies in the cardiovascular device arena. They serve as the highest level of evidence for… read more here.
Keywords: regulatory approval; involving cardiovascular; approval practice; guidelines involving ... See more keywords