Time to Publication Among Completed Clinical Trials

Joseph S. Ross · Marian Mocanu · Julianna F. Lampropulos · Tony Tse · Harlan M. Krumholz

114 citations0/0 files storedJAMA Internal Medicine

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Academic Publishing and Open Access Meta-analysis and systematic reviews Pharmaceutical industry and healthcare

Abstract

Prior studies have shown that 25% to 50% of clinical trials are never published.[1][2][3][4] However, among those published, we know little about the length of time required for publication in the peer-reviewed biomedical literature after study completion.Ioannidis previously demonstrated that a sample of randomized phase 2 and 3 trials conducted between 1986 and 1996 required nearly 2.5 years for publication, 5 while our more recent study of National Institutes of Health (NIH)-funded trials found that average time to publication was almost two years.4 We sought to determine time to publication for a recent and representative sample of trials published in 2009. METHODSWe examined clinical trials published during the 2009 calendar year that were indexed via MEDLINE and linked to a ClinicalTrials.govidentifier (NCT Number).6 We excluded articles that were not the first publication reporting on the clinical trial by reviewing article text for citations to and searching MEDLINE for earlier trial publications.We imputed completion dates based on the subject enrollment dates and the longest period of follow-up required for any outcome measure reported in the article.For trials without enrollment dates, we used the completion date provided on ClinicalTrials.gov;

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References

2008Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias 1998Effect of the Statistical Significance of Results on the Time to Completion and Publication of Randomized Efficacy Trials 2004Clinical Trial Registration 2004Clinical trial registration: a statement from the International Committee of Medical Journal Editors 2012Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis

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