Compliance with results reporting at ClinicalTrials.gov.
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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.).
Clinical Trials as Topic
National Library of Medicine (U.S.)
Proportional Hazards Models
Research Support as Topic
United States Food and Drug Administration
Published Version (Please cite this version)10.1056/NEJMsa1409364
Publication InfoAnderson, 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.
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Assistant Professor of Medicine
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
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.
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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