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Bias in reporting clinical trials

A H Bardy1

  • 1National Agency for Medicines, Pharmacological Department, Helsinki, Finland.

British Journal of Clinical Pharmacology
|September 2, 1998
PubMed
Summary

Selective reporting of clinical trial results was investigated. Positive outcomes were significantly more likely to be reported to regulatory authorities, indicating potential bias in drug safety assessments.

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Area of Science:

  • Pharmacovigilance
  • Clinical Trial Methodology
  • Regulatory Science

Background:

  • Selective reporting of clinical trial outcomes can distort the evidence base.
  • This bias may lead regulatory authorities to make suboptimal decisions regarding drug approval and safety monitoring.

Purpose of the Study:

  • To investigate the occurrence of selective reporting of clinical trial results submitted to the Finnish National Agency for Medicines.
  • To assess whether trial outcomes influence the likelihood of final report submission.

Main Methods:

  • A cohort of 274 clinical drug trials notified to the Finnish National Agency for Medicines between 1987 and 1993 was analyzed.
  • Outcomes (positive, inconclusive, negative) were classified, and final report submission rates were compared across outcome categories.
  • Sponsors of non-reported trials were prompted for outcome data.

Main Results:

  • Final reports were received for 38% of trials with positive outcomes, compared to 18% for inconclusive and 20% for negative outcomes.
  • A total of 111 trials had positive outcomes, 33 inconclusive, and 44 negative; 86 outcomes were unassessable.
  • The data indicate a higher rate of final report submission for trials with favorable results.

Conclusions:

  • Substantial evidence suggests selective reporting of clinical trial results.
  • Trials with positive outcomes were significantly more likely to have their final reports submitted to the regulatory authority.
  • This selective reporting practice may compromise the integrity of regulatory decision-making.

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