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NIH clinical trials and publication bias

K Dickersin1, Y I Min

  • 1Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine, Baltimore 21201.

The Online Journal of Current Clinical Trials
|April 28, 1993
PubMed
Summary

Clinical trial results showing significance are 12 times more likely to be published. Publication bias persists even with high publication rates, necessitating better trial registration systems.

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Area of Science:

  • Clinical research methodology
  • Biostatistics
  • Medical research ethics

Background:

  • Publication bias is a significant concern in medical research.
  • The likelihood of publication may be influenced by study findings and characteristics.
  • Ensuring all trial results are accessible is crucial for evidence-based medicine.

Purpose of the Study:

  • To examine factors associated with the publication of clinical trial results.
  • To identify whether study findings (significant vs. nonsignificant) impact publication rates.
  • To explore other trial characteristics that might influence publication.

Main Methods:

  • A cohort of 293 clinical trials funded by the National Institutes of Health (NIH) in 1979 was followed.
  • Publication status and trial results were determined through interviews by 1988.
  • Statistical analysis, including odds ratios, was used to assess associations.

Main Results:

  • Of 198 completed trials, 93% were published.
  • Trials with significant results were substantially more likely to be published (OR = 12.30).
  • No other investigated trial characteristic was positively associated with publication.

Conclusions:

  • Publication bias is a problem, even in well-funded studies like those from the NIH.
  • The tendency to publish only significant findings can distort the medical literature.
  • Improved trial registration systems are needed to ensure comprehensive data availability for meta-analysis and medical decision-making.

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