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Predictors of high residual gradient after transcatheter aortic valve replacement in bicuspid aortic valve stenosis Intravascular Ultrasound Guidance Is Associated With Better Outcome in Patients Undergoing Unprotected Left Main Coronary Artery Stenting Compared With Angiography Guidance Alone Regional Heterogeneity in the Coronary Vascular Response in Women With Chest Pain and Nonobstructive Coronary Artery Disease Association of Smoking Status With Long‐Term Mortality and Health Status After Transcatheter Aortic Valve Replacement: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry Cardiac resynchronization therapy with a defibrillator (CRTd) in failing heart patients with type 2 diabetes mellitus and treated by glucagon-like peptide 1 receptor agonists (GLP-1 RA) therapy vs. conventional hypoglycemic drugs: arrhythmic burden, hospitalizations for heart failure, and CRTd responders rate The Use of Sex-Specific Factors in the Assessment of Women’s Cardiovascular Risk Impact of Lesion Preparation Strategies on Outcomes of Left Main PCI: The EXCEL Trial Aortic Valve Stenosis Treatment Disparities in the Underserved JACC Council Perspectives Haemodynamic-guided management of heart failure (GUIDE-HF): a randomised controlled trial 2019 Guidelines on Diabetes, Pre-Diabetes and Cardiovascular Diseases developed in collaboration with the EASD ESC Clinical Practice Guidelines

Review Article2017 Aug 21 [Epub ahead of print]

JOURNAL:Rev Esp Cardiol (Engl Ed). Article Link

From Nonclinical Research to Clinical Trials and Patient-registries: Challenges and Opportunities in Biomedical Research

de la Torre Hernández JM, Edelman ER Keywords: Biomedical research; Clinical registry; Randomized clinical trial

ABSTRACT

The most important challenge faced by human beings is health. The only way to provide better solutions for health care is innovation, true innovation. The only source of true innovation is research, good research indeed. The pathway from a basic science study to a randomized clinical trial is long and not free of bumps and even landmines. These are all the obstacles and barriers that limit the availability of resources, entangle administrative-regulatory processes, and restrain investigators’ initiatives. There is increasing demand for evidence to guide clinical practice but, paradoxically, biomedical research has become increasingly complex, expensive, and difficult to integrate into clinical care with increased barriers to performing the practical aspects of investigation. We face the challenge of increasing the volume of biomedical research and simultaneously improving the efficiency and output of this research. In this article, we review the main stages and methods of biomedical research, from nonclinical studies with animal and computational models to randomized trials and clinical registries, focusing on their limitations and challenges, but also providing alternative solutions to overcome them. Fortunately, challenges are always opportunities in disguise.