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A multi-state model analysis of the time from ethical approval to publication of clinical research studies

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  • Anette Blümle
  • Tobias Haag
  • James Balmford
  • Gerta Rücker
  • Martin Schumacher
  • Nadine Binder

Abstract

Background: Results of medical research should be made publicly available in a timely manner to enable patients and health professionals to make informed decisions about health issues. We aimed to apply a multi-state model to analyze the overall time needed to publish study results, and to examine predictors of the timing of transitions within the research process from study initiation through completion/discontinuation to eventual publication. Methods: Using a newly developed multi-state model approach, we analysed the effect of different study-related factors on each of the transitions from study approval to eventual publication, using a data set of clinical studies approved by a German research ethics committee between 2000 and 2002. Results: Of 917 approved studies, 806 were included in our analyses. About half of the clinical studies which began were subsequently published as full articles, and the median time from study approval to publication was 10 years. Differences across model states were apparent; several factors were predictive of the transition from study approval to completion, while funding source and collaboration were predictive of the transition from completion to publication. Conclusions: The proposed multi-state model approach permits a more comprehensive analysis of time to publication than a simple examination of the transition from approval to publication, and thus the findings represent an advance on previous studies of this aspect of the research process.

Suggested Citation

  • Anette Blümle & Tobias Haag & James Balmford & Gerta Rücker & Martin Schumacher & Nadine Binder, 2020. "A multi-state model analysis of the time from ethical approval to publication of clinical research studies," PLOS ONE, Public Library of Science, vol. 15(3), pages 1-15, March.
    • Handle: RePEc:plo:pone00:0230797
    DOI: 10.1371/journal.pone.0230797
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    References listed on IDEAS

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    1. Barker, Chris, 2009. "The Mean, Median, and Confidence Intervals of the Kaplan-Meier Survival Estimate—Computations and Applications," The American Statistician, American Statistical Association, vol. 63(1), pages 78-80.
    2. Kerry Dwan & Carrol Gamble & Paula R Williamson & Jamie J Kirkham & the Reporting Bias Group, 2013. "Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias — An Updated Review," PLOS ONE, Public Library of Science, vol. 8(7), pages 1-37, July.
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