Portfolio of clinical research in adult cardiovascular disease as reflected in ClinicalTrials.gov.
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Cardiovascular medicine is widely regarded as a vanguard for evidence-based drug and technology development. Our goal was to describe the cardiovascular clinical research portfolio from ClinicalTrials.gov.We identified 40 970 clinical research studies registered between 2007 and 2010 in which patients received diagnostic, therapeutic, or other interventions per protocol. By annotating 18 491 descriptors from the National Library of Medicine's Medical Subject Heading thesaurus and 1220 free-text terms to select those relevant to cardiovascular disease, we identified studies that related to the diagnosis, treatment, or prevention of diseases of the heart and peripheral arteries in adults (n = 2325 [66%] included from review of 3503 potential studies). The study intervention involved a drug in 44.6%, a device or procedure in 39.3%, behavioral intervention in 8.1%, and biological or genetic interventions in 3.0% of the trials. More than half of the trials were postmarket approval (phase 4, 25.6%) or not part of drug development (no phase, 34.5%). Nearly half of all studies (46.3%) anticipated enrolling 100 patients or fewer. The majority of studies assessed biomarkers or surrogate outcomes, with just 31.8% reporting a clinical event as a primary outcome.Cardiovascular studies registered on ClinicalTrials.gov span a range of study designs. Data have limited verification or standardization and require manual processes to describe and categorize studies. The preponderance of small and late-phase studies raises questions regarding the strength of evidence likely to be generated by the current portfolio and the potential efficiency to be gained by more research consolidation.
Published Version (Please cite this version)10.1161/JAHA.113.000009
Publication InfoAlexander, Karen P; Kong, David F; Starr, Aijing Z; Kramer, Judith; Chiswell, Karen; Tasneem, Asba; & Califf, Robert M (2013). Portfolio of clinical research in adult cardiovascular disease as reflected in ClinicalTrials.gov. Journal of the American Heart Association, 2(5). pp. e000009. 10.1161/JAHA.113.000009. Retrieved from https://hdl.handle.net/10161/18160.
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Professor of Medicine
My research focus is on cardiovascular disease management and outcomes in special populations, specifically older adults. Historically there has been a lack of randomized controlled data regarding treatment efficacy and outcomes in this growing population. Because of this, certain therapies may have different risk benefit profiles, which may cause physicians to alter their therapeutic interventions. My research explores evidence based treatment for older adults, including preferences
Donald F. Fortin, M.D. Distinguished Professor of Cardiology, in the School of Medicine
Robert Califf, MD MACC, is the Donald F. Fortin, MD, Professor of Cardiology. He is also 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
Ph.D., North Carolina State University - 2007I work closely with clinical and quantitative colleagues to provide statistical leadership, guidance and mentoring on the design, execution, and analysis of clinical research studies. My work includes design and analysis of observational studies (including large cardiovascular registries, and clinical care databases linke
Associate Professor of Medicine
David F. Kong, M.D., A.M., D.M.T., F.A.C.C., F.S.C.A.I. is an Associate Professor of Medicine at Duke University Medical Center and Co-Director of the Cardiovascular Late Phase 3 and Devices Unit at the Duke Clinical Research Institute. An interventional cardiologist at Duke Hospital and a faculty member in the Duke Center for Healthcare Informatics, Dr. Kong specializes in cardiovascular informatics research and integration of evidence from cardiovascular clinical trials. Dr
Professor Emeritus of Medicine
· Studying methods to facilitate the uptake of evidence-based treatment recommendations. · Optimizing the use of drugs, devices, and biological products in clinical practice. · Studying methods of risk management for therapeutic products
Clinical Trials Project Leader II
Ph.D., University of Illinois at Urbana-Champaign - 2005 My overarching goal is to facilitate open science and open access of research data by providing thought leadership, guidance, and support to Duke researchers in data sharing. I work with Research Investigators and Statistical Scientists to manage data-driven projects. My work includes overseeing implementation of innovative software solutions in pragmatic clinical tr
Alphabetical list of authors with Scholars@Duke profiles.