Compliance with results reporting at ClinicalTrials.gov.
Abstract
BACKGROUND: The Food and Drug Administration Amendments Act (FDAAA) mandates timely
reporting of results of applicable clinical trials to ClinicalTrials.gov. We characterized
the proportion of applicable clinical trials with publicly available results and determined
independent factors associated with the reporting of results. METHODS: Using an algorithm
based on input from the National Library of Medicine, we identified trials that were
likely to be subject to FDAAA provisions (highly likely applicable clinical trials,
or HLACTs) from 2008 through 2013. We determined the proportion of HLACTs that reported
results within the 12-month interval mandated by the FDAAA or at any time during the
5-year study period. We used regression models to examine characteristics associated
with reporting at 12 months and throughout the 5-year study period. RESULTS: From
all the trials at ClinicalTrials.gov, we identified 13,327 HLACTs that were terminated
or completed from January 1, 2008, through August 31, 2012. Of these trials, 77.4%
were classified as drug trials. A total of 36.9% of the trials were phase 2 studies,
and 23.4% were phase 3 studies; 65.6% were funded by industry. Only 13.4% of trials
reported summary results within 12 months after trial completion, whereas 38.3% reported
results at any time up to September 27, 2013. Timely reporting was independently associated
with factors such as FDA oversight, a later trial phase, and industry funding. A sample
review suggested that 45% of industry-funded trials were not required to report results,
as compared with 6% of trials funded by the National Institutes of Health (NIH) and
9% of trials that were funded by other government or academic institutions. CONCLUSIONS:
Despite ethical and legal obligations to disclose findings promptly, most HLACTs did
not report results to ClinicalTrials.gov in a timely fashion during the study period.
Industry-funded trials adhered to legal obligations more often than did trials funded
by the NIH or other government or academic institutions. (Funded by the Clinical Trials
Transformation Initiative and the NIH.).
Type
Journal articleSubject
AlgorithmsClinical Trials as Topic
Databases, Factual
Disclosure
Drug Industry
Government Regulation
Humans
Mandatory Programs
National Library of Medicine (U.S.)
Proportional Hazards Models
Registries
Research Support as Topic
United States
United States Food and Drug Administration
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https://hdl.handle.net/10161/13024Published Version (Please cite this version)
10.1056/NEJMsa1409364Publication Info
Anderson, Monique L; Chiswell, Karen; Peterson, Eric D; Tasneem, Asba; Topping, James;
& Califf, Robert M (2015). Compliance with results reporting at ClinicalTrials.gov. N Engl J Med, 372(11). pp. 1031-1039. 10.1056/NEJMsa1409364. Retrieved from https://hdl.handle.net/10161/13024.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.
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Show full item recordScholars@Duke
Monique Anderson Starks
Assistant Professor of Medicine
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
Eric David Peterson
Fred Cobb, M.D. Distinguished Professor of Medicine
Dr Peterson is the Fred Cobb Distinguished Professor of Medicine in the Division of
Cardiology, a DukeMed Scholar, and the Past Executive Director of the Duke Clinical
Research Institute (DCRI), Durham, NC, USA.
Dr Peterson is the Principal Investigator of the National Institute of Health, Lung
and Blood Institute (NHLBI) Spironolactone Initiation Registry Randomized Interventional
Trial in Heart Failure With Preserved Ejection Fraction (SPIRRIT) Trial He is also
the Principal I
This author no longer has a Scholars@Duke profile, so the information shown here reflects
their Duke status at the time this item was deposited.
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
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