In randomized clinical trials, commercial sponsorship influences how studies are designed and the results reported in ways that often benefit the study’s sponsor, Weill Cornell Medicine and NewYork-Presbyterian investigators report in a new study. The findings underscore the need to improve study design, reporting and guidelines to avoid bias in these trials, the authors say.
The study, published June 1 in JAMA Internal Medicine, focuses on coronary, vascular and structural interventional cardiology, and vascular and cardiac surgeries because of the enormous burden cardiovascular disease places on public health. In the United States, it accounts for approximately 800,000 deaths per year and 6 percent of total dollars spent on healthcare. A rigorous approach to evaluating new interventions for heart disease is critical.
“In medicine in general, but in particular cardiovascular medicine, we see randomized clinical trials as the best form of evidence,” said lead author Dr. Mario Gaudino, a professor in cardiothoracic surgery and director of translational and clinical research in cardiothoracic surgery at Weill Cornell Medicine, and a cardiovascular surgeon at NewYork-Presbyterian/Weill Cornell Medical Center. “Our practice is very heavily influenced by the results of randomized clinical trials. If those trials are not properly performed and reported, there’s a risk that we use the wrong strategy and don’t treat patients in the best possible way.”
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