Portfolio of clinical research in adult cardiovascular disease as reflected in ClinicalTrials.gov.
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.
Type
Journal articlePermalink
https://hdl.handle.net/10161/18160Published Version (Please cite this version)
10.1161/JAHA.113.000009Publication Info
Alexander, 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.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
Collections
More Info
Show full item recordScholars@Duke
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
Robert M. Califf
Adjunct Professor 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
Karen Chiswell
Statistical Scientist
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
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
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
Asba Tasneem
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.

Articles written by Duke faculty are made available through the campus open access policy. For more information see: Duke Open Access Policy
Rights for Collection: Scholarly Articles
Works are deposited here by their authors, and represent their research and opinions, not that of Duke University. Some materials and descriptions may include offensive content. More info