Availability of results from clinical research: Failing policy efforts

Tatyana Shamliyan · Robert L Kane

23 citations0/0 files storedJournal of Epidemiology and Global Health

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Academic Publishing and Open Access Research Data Management Practices Pharmaceutical industry and healthcare

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.

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1990The Existence of Publication Bias and Risk Factors for Its Occurrence 2009Publication bias in clinical trials due to statistical significance or direction of trial results 2009Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials 1993Publication Bias: The Problem That Won't Go Away 2012Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis 1997How important is publication bias? A synthesis of available data.2007Why Most Published Research Findings Are False: Author's Reply to Goodman and Greenland 2013Linking ClinicalTrials.gov and PubMed to Track Results of Interventional Human Clinical Trials

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