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Data Safety and Monitoring Boards (DSMBs)

  • Stephen P. Glasser
  • O. Dale Williams

Abstract

Data Safety and Monitoring Boards were introduced as a mechanism for monitoring interim data in clinical trials as a way to ensure the safety of participating subjects. Procedures for and experience with DSMBs has expanded considerably over recent years and they are now required by the NIH for almost any interventional and for some observational trials. A DSMB’s primary role is to evaluate adverse events and to determine the relationship of the adverse event to the therapy (or device). Interim analyses and early termination of studies are two aspects of DSMBs that are particularly difficult. This chapter will discuss the role of DSMBs and address the aforementioned issues.

Keywords

Interim Analysis Data Safety Data Monitoring Committee Monitoring Board Interim Data 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Springer Science + Business Media B.V 2008

Authors and Affiliations

  • Stephen P. Glasser
    • 1
  • O. Dale Williams
    • 2
  1. 1.Univesity of Alabama at Birmingham, Birmingham, AlabamaBirmingham
  2. 2.Division of Preventive MedicineUnivesity of Alabama at BirminghamBirmingham

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