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2 results

  • 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.

  • 26 - Insomnia

  • from Section 6
  • Edited by Bernard Ravina, Jeffrey Cummings, Michael McDermott, R. Michael Poole
  • Book:
    Clinical Trials in Neurology
    Published online:
    05 May 2012
    Print publication:
    12 April 2012, pp 295-308

  • Summary

    Accumulating data may be reviewed regularly in all phases of clinical development for decision-making based on safety or clinical benefit. This chapter discusses the process of reviewing accumulating clinical trial data in a formal manner. It provides an overview of the structure and the operations of a data monitoring committee (DMC), and elucidates the statistical issues and challenges of interim monitoring. The chapter describes several commonly used approaches for interim monitoring. Multi-center trials must be coordinated and administered efficiently. A DMC's objectivity is in part due to independence of the members. A formal statistical framework can enhance the objectivity by providing a universal language to communicate the accumulating evidence. Group sequential methods for determining the critical values to be used during interim analyses represent a key advancement in the theory and application of sequential analyses. EAST is highly regarded as an excellent tool for interim monitoring of clinical trials.