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A call for error management in academic clinical research

  • Stuart McLennan
    Correspondence
    Corresponding author. Institute of History and Ethics in Medicine, TUM School of Medicine, Technical University of Munich, Ismaninger Straße 22, 81675 Munich, Germany. Tel.: +49 89 4140 4041; fax: +49 89 4140 4970.
    Affiliations
    Institute of History and Ethics in Medicine, TUM School of Medicine, Technical University of Munich, Munich, Germany
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  • Matthias Briel
    Affiliations
    CLEAR Methods Center, Division of Clinical Epidemiology, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland

    Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada
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Published:December 04, 2022DOI:https://doi.org/10.1016/j.jclinepi.2022.11.023

      Highlights

      • Although the realization of the alarming frequency, harm, and costs of errors in clinical care has led to error management systems being widely implemented, there have been no similar efforts to manage errors or failures in academic investigator-initiated clinical research.
      • Errors and failures frequently occur in clinical research and can negatively impact research quality, potentially contributing to significant wasted resources and patient harm. There is an urgent need to implement error management in academic clinical research.
      • Specific strategies that can assist error management in clinical research include error reporting systems so that lessons can be learnt, a systematic approach to disclosing errors to clinical research participants, and emotional support being proactively offered to investigators involved in errors.
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