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  • 22 - Data Safety Monitoring Boards in Alzheimer’s Disease Trials

  • from Section 3 - Alzheimer’s Disease Clinical Trials
  • Edited by Jeffrey Cummings, University of Nevada, Las Vegas, Jefferson Kinney, University of Nevada, Las Vegas, Howard Fillit
  • Book:
    Alzheimer's Disease Drug Development
    Published online:
    03 March 2022
    Print publication:
    31 March 2022, pp 266-274

  • Summary

    The data safety monitoring board (DSMB), also known the data monitoring committee, is a multidisciplinary team of scientific experts that serve an advisory role within the operation of clinical trials. The principle responsibility of a DSMB is to monitor the conduct of trials for concerns related to participant safety and data quality through the review of interim data analyses, and then to advise trial leadership whether a study is appropriate to continue, needs to modify procedures, or should be terminated. An emphasis is placed on the responsibility of the DSMB to safeguard the rights and well-being of study participants, so it is common to see the incorporation of a DSMB into a study protocol when a trial explores an intervention with high participant risk, a trial is working with a large number of participants, or when a study is working with a particularly vulnerable population, like Alzheimer’s disease (AD) patients. This chapter reviews common DSMB roles and responsibilities as well as highlighting examples of DSMBs in practice in AD clinical research.