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Issues for Masked Data Monitoring

In: Principles and Practice of Clinical Trials

Author

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  • O. Dale Williams

    (University of North Carolina, Department of Biostatistics
    University of Alabama at Birmingham, Department of Medicine)

  • Katrina Epnere

    (WCG Statistics Collaborative)

Abstract

The essential, primary purpose of a clinical trial is to provide a fair test for the comparison of treatments, drugs, strategies, etc. A challenge to this fairness is the appropriate utilization, or lack thereof, of masking or blinding. Masking generally refers to restricting knowledge as to the treatment group assignment for the individual or, in the case of a Data and Safety Monitoring Board (DSMB), to the summary of information comparing treatment groups. Fundamentally, masking is important to consider for those situations wherein knowledge of the treatment assignment could alter behavior or otherwise impact inappropriately on trial results. Masking may, however, while protecting against this bias, make it more difficult for the DSMB properly to protect trial participants from undue risk of adverse or serious adverse events. While there are several dimensions to this overall situation, this chapter addresses the important issue as to whether a trial’s DSMB should be fully aware of which treatment group is which as it reviews data summaries for an ongoing trial.

Suggested Citation

  • O. Dale Williams & Katrina Epnere, 2022. "Issues for Masked Data Monitoring," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 45, pages 823-832, Springer.
    • Handle: RePEc:spr:sprchp:978-3-319-52636-2_217
    DOI: 10.1007/978-3-319-52636-2_217
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