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Compliance with results reporting at ClinicalTrials.gov.

dc.contributor.author Anderson, Monique L
dc.contributor.author Chiswell, Karen
dc.contributor.author Peterson, Eric D
dc.contributor.author Tasneem, Asba
dc.contributor.author Topping, James
dc.contributor.author Califf, Robert M
dc.coverage.spatial United States
dc.date.accessioned 2016-11-30T19:52:30Z
dc.date.issued 2015-03-12
dc.identifier http://www.ncbi.nlm.nih.gov/pubmed/25760355
dc.identifier.uri https://hdl.handle.net/10161/13024
dc.description.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.).
dc.language eng
dc.publisher Massachusetts Medical Society
dc.relation.ispartof N Engl J Med
dc.relation.isversionof 10.1056/NEJMsa1409364
dc.subject Algorithms
dc.subject Clinical Trials as Topic
dc.subject Databases, Factual
dc.subject Disclosure
dc.subject Drug Industry
dc.subject Government Regulation
dc.subject Humans
dc.subject Mandatory Programs
dc.subject National Library of Medicine (U.S.)
dc.subject Proportional Hazards Models
dc.subject Registries
dc.subject Research Support as Topic
dc.subject United States
dc.subject United States Food and Drug Administration
dc.title Compliance with results reporting at ClinicalTrials.gov.
dc.type Journal article
duke.contributor.id Anderson, Monique L|0510510
duke.contributor.id Chiswell, Karen|0330888
duke.contributor.id Peterson, Eric D|0130909
duke.contributor.id Tasneem, Asba|0540369
duke.contributor.id Califf, Robert M|0031646
pubs.author-url http://www.ncbi.nlm.nih.gov/pubmed/25760355
pubs.begin-page 1031
pubs.end-page 1039
pubs.issue 11
pubs.organisational-group Clinical Science Departments
pubs.organisational-group Duke
pubs.organisational-group Duke Clinical Research Institute
pubs.organisational-group Institutes and Centers
pubs.organisational-group Medicine
pubs.organisational-group Medicine, Cardiology
pubs.organisational-group School of Medicine
pubs.organisational-group Staff
pubs.publication-status Published
pubs.volume 372
dc.identifier.eissn 1533-4406
duke.contributor.orcid Chiswell, Karen|0000-0002-0279-9093
duke.contributor.orcid Peterson, Eric D|0000-0002-5415-4721


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