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Issues for Masked Data Monitoring

  • O. Dale WilliamsEmail author
  • Katrina Epnere
Living reference work entry

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.

Keywords

Data and safety monitoring board Data monitoring committee Masking Blinding Open report Closed report Interim analysis Risk/benefit 

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Online Documents

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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.Department of MedicineUniversity of AlabamaBirminghamUSA
  2. 2.Statistics Collaborative Inc.WashingtonUSA

Section editors and affiliations

  • O. Dale Williams
    • 1
  1. 1.Department of MedicineUniversity of AlabamaBirminghamUSA

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