Portfolio of clinical research in adult cardiovascular disease as reflected in ClinicalTrials.gov.

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2013-09-26

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Abstract

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.

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Humans, Cardiovascular Diseases, Registries, Biomedical Research, Internet, Clinical Trials as Topic

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Published Version (Please cite this version)

10.1161/JAHA.113.000009

Publication Info

Alexander, Karen P, David F Kong, Aijing Z Starr, Judith Kramer, Karen Chiswell, Asba Tasneem and Robert M Califf (2013). Portfolio of clinical research in adult cardiovascular disease as reflected in ClinicalTrials.gov. Journal of the American Heart Association, 2(5). p. e000009. 10.1161/JAHA.113.000009 Retrieved from https://hdl.handle.net/10161/18160.

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Scholars@Duke

Alexander

Karen Patton Alexander

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 and decision-making as well as frailty and aging assessments in clinical trials and registries. Diagnosis and management of stable ischemic heart disease is also an area of focus.

Kong

David Franklin Kong

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. Kong graduated magna cum laude from HarvardUniversity, where he also received a master’s degree in Organismic and Evolutionary Biology. He received his medical degree from the Johns Hopkins University School of Medicine, and was a resident on the Osler Medical Service at the JohnsHopkinsHospital. He completed fellowships in Cardiovascular Disease and Interventional Cardiovascular Medicine at DukeUniversity before joining the Duke faculty.  Dr. Kong is board certified in internal medicine, cardiology, and interventional cardiology. He is a Certified Diver Medic, Master Diver, and Dive Medical Examiner, and has been elected Fellow of the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions.

Kramer

Judith Mae Kramer

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

Chiswell

Karen Chiswell

Statistical Scientist

Ph.D., North Carolina State University - 2007

I 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 linked with electronic health record data) and early-phase trials in pediatric populations. My statistical interests include study design, linear and non-linear mixed effects models, survival analysis, biology- and mechanism-based models, and statistical thinking and learning. 

Califf

Robert M. Califf

Instructor in the Department of Medicine

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.


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