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Editor's Note
March 18, 2020

Lessons From the Rationale and Design Features of the ADAPTABLE Trial

Author Affiliations
  • 1Cardiovascular Division, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
  • 2Deputy Editor, JAMA Cardiology
JAMA Cardiol. Published online March 18, 2020. doi:10.1001/jamacardio.2020.0328

Leading clinical trialists have for several years called for fundamental changes to the clinical research enterprise. Although randomized clinical trials remain the gold standard by which the efficacy and safety of an intervention are best assessed, their associated costs, size, complexity, duration, and limited generalizability have accentuated the need for innovative trial designs to facilitate simpler, faster, and more efficient means to answer meaningful clinical questions that matter to patients and the public. The Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia (TASTE) trial1 combined randomized treatment assignment (manual thrombus aspiration plus primary percutaneous coronary intervention vs primary percutaneous coronary intervention alone) within a high-quality, large-scale national registry, thereby highlighting the exciting potential for the approach termed randomized registry trials to be executed more quickly and at a fraction of the cost of a traditional randomized clinical trial posing the same question. A small randomized clinical trial embedded within the CathPCI Registry, supported by the American College of Cardiology, was subsequently reported,2 but to date there has been very little movement in this direction within the United States.