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  • 1.  DSMB

    Posted 12-12-2023 14:43

    Hello All,

    I enjoy this group and the valuable feedback.  I have a question.  I am a biostatistician and do some consulting on the side through my LLC.  My projects are typically relatively small analyses for startup diagnostic and medical companies.  My experience contributing to active clinical trials is limited and I have been asked to be on a DSMB for a study in Europe.  The company was asked to include a statistician on the DSMB as part of a review.  My question is if this (being on the DSMB) includes risks (legal or otherwise) I may not be aware of.  If so, what are they and how do you mitigate them?  I welcome and appreciate any thoughts.

    Thank you!

    -Derek



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    Derek Blankenship
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  • 2.  RE: DSMB

    Posted 12-12-2023 14:54

    Hi Derek,

    I recommend you check out these two articles. The second one gives an example of an indemnification agreement template.

    DeMets, D. L., Fleming, T. R., Rockhold, F., Massie, B., Merchant, T., Meisel, A., ... & Califf, R. (2004). Liability issues for data monitoring committee members. Clinical Trials, 1(6), 525-531.

    Fleming, T. R., Ellenberg, S. S., & DeMets, D. L. (2018). Data monitoring committees: current issues. Clinical Trials, 15(4), 321-328.

    Best,

    Haley



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    Haley Hedlin
    hedlin@stanford.edu
    JSM 2024 Program Chair for the Statistical Consulting Section
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    Original Message


  • 3.  RE: DSMB

    Posted 12-12-2023 14:58

    The authoritative book on that and many other DSMB  topics is by Ellenberg, DeMets, and Fleming. There definitely are risks, though I'm not aware of any statistician who has been taken to court for their role in a DSMB.

    https://www.amazon.com/Data-Monitoring-Committees-Clinical-Trials/dp/0471489867

    Make sure you order  the most recent edition.  I also had the honor to prepare a book review of it in the American Statistician https://www.tandfonline.com/doi/full/10.1080/00031305.2022.2088199



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    Chris Barker, Ph.D.
    2023 Chair Statistical Consulting Section
    Consultant and
    Adjunct Associate Professor of Biostatistics
    www.barkerstats.com


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    "In composition you have all the time you want to decide what to say in 15 seconds, in improvisation you have 15 seconds."
    -Steve Lacy
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    Original Message


  • 4.  RE: DSMB

    Posted 12-12-2023 16:19

    Data and Safety Monitoring Committees in Clinical Trials (Chapman & Hall/CRC Biostatistics Series) 2nd Edition

    by Jay Herson (Author)

    "Given the author's years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this book―not only for experts because of its cogent and organized presentation, but more importantly for young investigators who are seeking information about the logistical and philosophical aspects of a DMC."

    -S. T. Ounpraseuth, The American Statistician



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    Greg Ball
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    Original Message