Randomized Trials Versus Common Sense and Clinical Observation: JACC Review Topic of the Week.
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2020-08
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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.
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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
Robert M. Califf
Robert Califf, MD MACC, is an Adjunct Professor of Medicine in the Division of Cardiology and remains a practicing cardiologist. Dr. Califf was the Commissioner of Food and Drugs in 2016-2017 and Deputy Commissioner for Medical Products and Tobacco from February 2015 until his appointment as Commissioner in February 2016. Prior to joining the FDA, Dr. Califf was a professor of medicine and vice chancellor for clinical and translational research at Duke University. He also served as director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute. A nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, healthcare quality, and clinical research, Dr. Califf has led many landmark clinical trials and is one of the most frequently cited authors in biomedical science, with more than 1,200 publications in the peer-reviewed literature.
Dr. Califf is a Member of the National Academy of Medicine (formerly known as the Institute of Medicine (IOM)) in 2016, one of the highest honors in the fields of health and medicine. Dr. Califf has served on numerous IOM committees, and he has served as a member of the FDA Cardiorenal Advisory Panel and FDA Science Board's Subcommittee on Science and Technology. Dr. Califf has also served on the Board of Scientific Counselors for the National Library of Medicine, as well as on advisory committees for the National Cancer Institute, the National Heart, Lung, and Blood Institute, the National Institute of Environmental Health Sciences and the Council of the National Institute on Aging.
He has led major initiatives aimed at improving methods and infrastructure for clinical research, including the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by the FDA and Duke. He also served as the principal investigator for Duke's Clinical and Translational Science Award and the NIH Health Care Systems Research Collaboratory coordinating center and co-PI of the Patient Centered Outcomes Research Institute Network.
Christopher Bull Granger
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.
John Hunter Peel Alexander
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).
Renato Delascio Lopes
Atrial Fibrillation
Antithrombotic Therapy in patients with Acute Coronary Syndromes
Elderly patients with Heart Disease
Biomarkers in Acute Coronary Syndromes and Atrial Fibrillation
Thrombosis and Anticoagulation and novel antithrombotic agents
Metabolomics in Cardiovascular Medicine
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