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Journal editors impasse with outcome reporting bias.

Rafael Dal-Ré1, Arthur L Caplan2

  • 1Clinical Research, BUC (Biosciences UAM+CSIC) Programme, International Campus of Excellence, Universidad Autónoma de Madrid, Madrid, Spain.

European Journal of Clinical Investigation
|June 26, 2015
PubMed
Summary

Ensuring clinical trial transparency requires more than just data access. Implementing robust editorial quality-control processes is crucial to prevent outcome reporting bias and enhance scientific integrity.

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Area of Science:

  • Clinical research methodology
  • Medical ethics
  • Scientific publishing

Background:

  • Clinical trial transparency is mandated through prospective registration, results disclosure, regulatory report access, and anonymized patient-level data sharing.
  • Dissemination of clinical trial results via articles often suffers from outcome reporting bias.
  • While open data access can mitigate this bias, it is insufficient on its own.

Purpose of the Study:

  • To discuss existing and proposed strategies for preventing outcome reporting bias in clinical trial publications.
  • To evaluate the effectiveness of current measures, such as journal staff access to protocols.
  • To advocate for enhanced editorial quality-control processes in scientific publishing.

Main Methods:

  • Review of current regulations and proposals concerning clinical trial transparency and bias prevention.

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  • Analysis of the efficacy of journal access to trial protocols in mitigating outcome reporting bias.
  • Discussion of two key proposals aimed at tackling outcome reporting bias.

    • Main Results:

    • Prospective registration and data access are essential but do not fully prevent outcome reporting bias.
    • Journal staff access to protocols has been largely ineffective in preventing outcome reporting bias.
    • Specific editorial quality-control processes are proposed as a necessary measure.

    Conclusions:

    • Effective prevention of outcome reporting bias requires a multi-faceted approach beyond data and protocol access.
    • Editors must implement and report on the efficiency of quality-control processes to ensure unbiased reporting.
    • Enhanced transparency and rigorous editorial oversight are vital for trustworthy clinical trial dissemination.