Journal of Epidemiology and Global Health

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Volume 4, Issue 1, March 2014, Pages 1 - 12

Availability of results from clinical research: Failing policy efforts

Authors
Tatyana A. Shamliyana, b, c, *, t.shamliyan@elsevier.com, Robert L. Kanea, b
aDivision of Health Policy and Management, University of Minnesota School of Public Health, Minneapolis, MN, United States
bMinnesota Evidence-based Practice Center, Minneapolis, MN, United States
cElsevier Clinical Solutions, Evidence-Based Medicine Center, United States
*Corresponding author at: Evidence-Based Medicine Quality Assurance, Elsevier, 1600 JFK Blvd 20th floor, Philadelphia, PA 19103, United States. Tel.: +1 215 239 3821x3821.
Corresponding Author
Tatyana A. Shamliyant.shamliyan@elsevier.com
Received 23 March 2013, Revised 20 August 2013, Accepted 24 August 2013, Available Online 23 September 2013.
DOI
10.1016/j.jegh.2013.08.002How to use a DOI?
Keywords
Evidence based medicine; Clinical research Standards; Publication bias; Clinical epidemiology
Abstract

Objectives: Trial registration has a great potential to increase research transparency and public access to research results. This study examined the availability of results either in journal publications or in the trial registry from all studies registered at ClinicalTrials.gov.

Methods: All 137,612 records from ClinicalTrials.gov in December 2012 were merged with all 19,158 PubMed records containing registration numbers in the indexing field or in the abstracts. A multivariate analysis was conducted to examine the association between the availability of the results with study and participant characteristics available in registration records.

Results: Fewer than 10% of the registered studies and 15% of the registered and completed studies had published results. The highest publication rate of 22.4% was for randomized trials completed between 2005 (starting year for structured indexing in PubMed of study registration) and 2010. For 86% of overall and 78% of completed registered studies, no results were available in ClinicalTrials.gov or in journal publications. Studies funded by industry vs. other funding sources and drug studies vs. all studies of other interventions were published less often after adjustment for study type, subject characteristics, or posting of results in ClinicalTrials.gov.

Conclusion: Existing policy does not ensure availability of results from clinical research. International policy revisions should charge principal investigators with ensuring that the approved protocols and posted data elements are aligned and that results are available from all conducted studies.

Copyright
© 2013 Ministry of Health, Saudi Arabia. Published by Elsevier Ltd.
Open Access
This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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Next Article In Issue>
Journal
Journal of Epidemiology and Global Health
Volume-Issue
4 - 1
Pages
1 - 12
Publication Date
2013/09/23
ISSN (Online)
2210-6014
ISSN (Print)
2210-6006
DOI
10.1016/j.jegh.2013.08.002How to use a DOI?
Copyright
© 2013 Ministry of Health, Saudi Arabia. Published by Elsevier Ltd.
Open Access
This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Cite this article

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TY  - JOUR
AU  - Tatyana A. Shamliyan
AU  - Robert L. Kane
PY  - 2013
DA  - 2013/09/23
TI  - Availability of results from clinical research: Failing policy efforts
JO  - Journal of Epidemiology and Global Health
SP  - 1
EP  - 12
VL  - 4
IS  - 1
SN  - 2210-6014
UR  - https://doi.org/10.1016/j.jegh.2013.08.002
DO  - 10.1016/j.jegh.2013.08.002
ID  - Shamliyan2013
ER  -