The Changing Landscape of Randomized Clinical Trials in Cardiovascular Disease

J Am Coll Cardiol. 2016 Oct 25;68(17):1898-1907. doi: 10.1016/j.jacc.2016.07.781.


Large randomized clinical trials in cardiovascular disease have proliferated over the past 3 decades, with results that have influenced every aspect of cardiology practice. Despite these advances, there remains a substantial need for more high-quality evidence to inform cardiovascular clinical practice, given the increasing prevalence of cardiovascular disease around the world. Traditional clinical trials are increasingly challenging due to rising costs, increasing complexity and length, and burdensome institutional and regulatory requirements. This review will examine the current landscape of cardiovascular clinical trials in the United States, highlight recently conducted registry-based clinical trials, and discuss the potential attributes of the recently launched pragmatic clinical trial by the Patient-Centered Outcomes Research Institute's National Patient-Centered Clinical Research Network, called the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing the Benefits and Long-term Effectiveness) trial.

Keywords: Patient-Centered Outcomes Research Institute; aspirin; coronary artery disease; pragmatic clinical trial.

Publication types

  • Review
  • Research Support, U.S. Gov't, P.H.S.
  • Research Support, N.I.H., Extramural

MeSH terms

  • Cardiovascular Diseases / therapy*
  • Humans
  • Pragmatic Clinical Trials as Topic
  • Randomized Controlled Trials as Topic* / methods
  • Randomized Controlled Trials as Topic* / standards
  • Registries
  • United States