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Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study

Prayle, A.P.; Hurley, M.N.; Smyth, Alan R.

Authors

A.P. Prayle

M.N. Hurley

Alan R. Smyth

Abstract

Objective To examine compliance with mandatory reporting of summary clinical trial results (within one year of completion of trial) on ClinicalTrials.gov for studies that fall under the recent Food and Drug Administration Amendments Act (FDAAA) legislation.

Design Registry based study of clinical trial summaries.

Data sources ClinicalTrials.gov, searched on 19 January 2011, with cross referencing with Drugs@FDA to determine for which trials mandatory reporting was required within one year.

Selection criteria Studies registered on ClinicalTrials.gov with US sites which completed between 1 January and 31 December 2009.

Main outcome measure Proportion of trials for which results had been reported.

Results The ClinicalTrials.gov registry contained 83 579 entries for interventional trials, of which 5642 were completed within the timescale of interest. We identified trials as falling within the mandatory reporting rules if they were covered by the FDAAA (trials of a drug, device, or biological agent, which have at least one US site, and are of phase II or later) and if they investigated a drug that already had approval from the Food and Drug Administration. Of these, 163/738 (22%) had reported results within one year of completion of the trial compared with 76/727 (10%) trials that were not subject to mandatory reporting (95% confidence interval for the difference in proportions 7.8% to 15.5%; χ2 test, P=2.6×10−9). Later phase trials were more likely to report results (P=4.4×10−11), as were industry funded trials (P=2.2×10−16).

Conclusion Most trials subject to mandatory reporting did not report results within a year of completion.

Journal Article Type Article
Publication Date Jan 3, 2012
Journal BMJ: British Medical Journal
Electronic ISSN 0959-8138
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 2011
Issue 344
Article Number d7373
Institution Citation Prayle, A., Hurley, M., & Smyth, A. R. (2012). Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study. BMJ, 2011(344), doi:10.1136/bmj.d7373
DOI https://doi.org/10.1136/bmj.d7373
Publisher URL http://www.bmj.com/content/344/bmj.d7373
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by-nc/4.0
Additional Information “The Corresponding Author has the right to grant on behalf of all authors and does grant on behalf of all authors, a worldwide licence to the Publishers and its licensees in perpetuity, in all forms, formats and media (whether known now or created in the future), to i) publish, reproduce, distribute, display and store the Contribution, ii) translate the Contribution into other languages, create adaptations, reprints, include within collections and create summaries, extracts and/or, abstracts of the Contribution, iii) create any other derivative work(s) based on the Contribution, iv) to exploit all subsidiary rights in the Contribution, v) the inclusion of electronic links from the Contribution to third party material where-ever it may be located; and, vi) licence any third party to do any or all of the above.”

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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by-nc/4.0




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