Cited by 244Pharmaceutical industry and healthcareMeta-analysis and systematic reviewsAcademic Publishing and Open Access

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Time to publication for results of clinical trials

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Hopewell, Sally, Clarke, Mike J, Stewart, Lesley, Tierney, Jayne·2007·Cochrane Database of Systematic Reviews

DOI 10.1002/14651858.mr000011.pub2PMC PMC7437393

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Abstract

BACKGROUND: It has been suggested that a time-lag bias exists whereby research studies with striking results are more likely to be stopped earlier than originally planned, published quicker, or both. If time-lag bias exists, new interventions might be mistakenly assumed to be effective. OBJECTIVES: To study the extent to which time to publication of a clinical trial is influenced by the significance of its result. SEARCH STRATEGY: Studies were identified by searching the Cochrane Methodology Register (The Cochrane Library, Issue 3, 2005), MEDLINE (1966 to May 2005), EMBASE (1980 to May 2005), Science Citation Index (June 2005) and by handsearching journals and conference abstracts. SELECTION CRITERIA: Studies were eligible if they contained analyses of any aspect of the time to publication of clinical trials and tracked the publication of a cohort of clinical trials. DATA COLLECTION AND ANALYSIS: Data extraction was performed independently by two authors. Data were extracted on the median time from the date the trial started to the date of publication. Data were also extracted on source of trials under investigation; source of funding; area of health care; means by which the publication status of these trials were sought; and methodological quality of the empirical study. MAIN RESULTS: Two studies with a total of 196 trials met the inclusion criteria. In both studies just over half of all trials had been published in full. Trials with positive results (i.e. statistically significant in favour of the experimental arm) were published in approximately 4 to 5 years. Trials with null or negative results (i.e. not statistically significant or statistically significant in favour of the control arm) were published after about 6 to 8 years. One study suggested that this difference could, in part, be attributed to the length of time taken to publish the results of a trial once follow up has been completed. This study showed that trials with null or negative findings took, on average, just over a year longer to be published than those with positive results. AUTHORS' CONCLUSIONS: Our review shows that trials with positive results are published sooner than other trials. This has important implications for the timing of the initiation and updating of a review, especially if there is an association between the inclusion of a trial in a review and its publication status. It is of particular concern when one considers reviews containing only a small number of studies.

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Authors: Hopewell, S., Clarke, M. J., Stewart, L., & Tierney, J.
Affiliations: National Institute for Health and Care Research (GB)
MRC Clinical Trials Unit at UCL (GB)
Medical Research Council (GB)
ORCID: Hopewell, Sally
Clarke, Mike J
Stewart, Lesley
Tierney, Jayne
Venue: Cochrane Database of Systematic Reviews
Publisher: Wiley
Published: 2007-04-18
Volume: 2010
Issue: 1
Pages: MR000011-MR000011
ISSN: 1361-6137 (ISSN-L)
1465-1858
DOI: 10.1002/14651858.mr000011.pub2
PMC: PMC7437393
OpenAlex: W2108513996
Cited by: 243
References: 23
Citations by year: 2026: 3 · 2025: 5 · 2024: 6 · 2023: 9 · 2022: 4 · 2021: 11 · 2020: 15 · 2019: 16 · 2018: 15 · 2017: 13 · 2016: 14 · 2015: 11 · 2014: 12 · 2013: 13 · 2012: 16
FWCI: 17.23
Type: journal article
Language: en
Update notices: new_version (2024-11-27)
Open access: green
www.ncbi.nlm.nih.gov
Locations: Cochrane Database of Systematic Reviews (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Nursing › Issues, ethics and legal aspects › Pharmaceutical industry and healthcare
Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Social Sciences › Library and Information Sciences › Academic Publishing and Open Access
Keywords: time to publication, clinical trials, positive results, publication status
MeSH terms: Clinical Trials as Topic, Publishing, Time Factors, Treatment Outcome, Publication Bias

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