Randomized Trials Versus Common Sense and Clinical Observation: JACC Review Topic of the Week.

Abstract

Concerns about the external validity of traditional randomized clinical trials (RCTs), together with the widespread availability of real-world data and advanced data analytic tools, have led to claims that common sense and clinical observation, rather than RCTs, should be the preferred method to generate evidence to support clinical decision-making. However, over the past 4 decades, results from well-done RCTs have repeatedly contradicted practices supported by common sense and clinical observation. Common sense and clinical observation fail for several reasons: incomplete understanding of pathophysiology, biases and unmeasured confounding in observational research, and failure to understand risks and benefits of treatments within complex systems. Concerns about traditional RCT models are legitimate, but randomization remains a critical tool to understand the causal relationship between treatments and outcomes. Instead, development and promulgation of tools to apply randomization to real-world data are needed to build the best evidence base in cardiovascular medicine.

Department

Description

Provenance

Citation

Published Version (Please cite this version)

10.1016/j.jacc.2020.05.069

Publication Info

Fanaroff, Alexander C, Robert M Califf, Robert A Harrington, Christopher B Granger, John JV McMurray, Manesh R Patel, Deepak L Bhatt, Stephan Windecker, et al. (2020). Randomized Trials Versus Common Sense and Clinical Observation: JACC Review Topic of the Week. Journal of the American College of Cardiology, 76(5). pp. 580–589. 10.1016/j.jacc.2020.05.069 Retrieved from https://hdl.handle.net/10161/21563.

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Scholars@Duke

Granger

Christopher Bull Granger

Donald F. Fortin, M.D. Distinguished Professor of Medicine

Research:
My primary research interest is in conduct and methodology of large randomized clinical trials in heart disease. I have led a number of large international clinical studies in heart attacks, unstable angina, heart failure, and atrial fibrillation. I have lead clinical studies of blood thinners and coronary intervention for heart attacks, stroke prevention in atrial fibrillation, and prevention of heart attack for patients with coronary artery disease. I have been co-director of the Reperfusion of Acute MI in Carolina Emergency Departments (RACE) project that is a North Carolina state-wide program to improve reperfusion care for acute myocardial infarction. I serve as the Chairman of the American Heart Association Mission: Lifeline program to improve heart attack care nationally as well as the American College of Cardiology/American Heart Association guideline committee for heart attack care. I have also studied the effects of genetic variation on heart disease. I work with the National Institute of Health and the Federal Drug Administration on evaluation of heart disease and of new drugs. I have developed tools to predict which patients are at risk for death, heart attack, and need for hospitalization.

Patel

Manesh Raman Patel

Richard Sean Stack, M.D. Distinguished Professor

Manesh Patel is the Chief of the Division of Cardiology and the Division of Clinical Pharmacology.  His clinical interests include diagnostic and interventional coronary angiography, peripheral angiography and endovascular intervention.  His is involved in several clinical trials involving patients with cardiovascular disease and in cardiac imaging.  He is also the Chair of the American College of Cardiology Task Force for Appropriate Use Criteria for Cardiovascular Procedures and is Chair of the American Heart Association Diagnostic and Interventional Cath Committee.

Patel's interest in cardiac imaging, quality of care, cardiac devices is also evident in his research.  His integration of these efforts into his roles at Duke was recognized in 2010 when he received the prestigious Duke Cardiology Fellowship Mentor Award.   In 2011, Dr. Patel was named the endowed John Bush Simpson Assistant Professor of Cardiology.  In 2013, Dr. Patel received the Robert M. Califf Faculty clinical research Award.

Currently, Dr. Patel is leading an effort to redesign the delivery of care to patients undergoing invasive catheterization procedures in the health system with a specific aim of measure and providing individualized, patient centered, innovative, and efficient care.

Alexander

John Hunter Peel Alexander

Professor of Medicine

John H. Alexander, MD, MHS is a cardiologist and Professor of Medicine in the Department of Medicine, Division of Cardiology at Duke University School of Medicine, as well as the Vice Chief, Clinical Research in the Division of Cardiology. He is the Director of Cardiovascular Research at the Duke Clinical Research Institute where he oversees a large group of clinical research faculty and a broad portfolio of cardiovascular clinical trials and observational clinical research programs. He is a member of the American Society of Clinical Investigation.

Dr. Alexander’s clinical interests are in acute and general cardiovascular disease, valvular heart disease, and echocardiology. His research is focused on the translation of novel therapeutic concepts into clinical data through clinical trials, specifically on the therapeutics of acute coronary syndromes, chronic coronary artery disease, and cardiac surgery and on novel methodological approaches to clinical trials. He was on the Executive Committee of the ARISTOTLE trial of apixaban in patients with atrial fibrillation and was the Principal Investigator of the APPRAISE-2 trial of apixaban in patients with acute coronary syndromes.

Dr. Alexander has published extensively and has served as the principal investigator of numerous multicenter clinical trials. He currently serves as the co-chair of the Clinical Trial Transformation Initiative (CTTI).


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