Regulatory Open Forum

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  • 1.  Statistical Analysis Plan

    Posted 26-Feb-2018 15:08
    Hello Colleagues,

    Who reviews Statistical Analysis Plans (SAP) at the FDA, statistical reviewers in the Division or statisticians in the Office of Biostatistics?

    Thank you for your assistance.

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    David Lucking
    FL
    United States
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  • 2.  RE: Statistical Analysis Plan

    Posted 27-Feb-2018 08:19
    It's driven by Study design and analysis complexity.  

    Phil Lavin

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    Philip Lavin
    Principal, Lavin Consulting LLC
    Framingham MA
    United States
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    Original Message


  • 3.  RE: Statistical Analysis Plan

    Posted 27-Feb-2018 08:30
    The statistical reviewer(s) that participate on CDER review teams is assigned from the Office of Biostatistics.

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    Glen Park
    Jersey City NJ
    United States
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    Original Message


  • 4.  RE: Statistical Analysis Plan

    Posted 27-Feb-2018 12:22
    ​Glen, do you know if that is for all statistical analysis plans, or just for those for clinical trials?

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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
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    Original Message


  • 5.  RE: Statistical Analysis Plan

    Posted 28-Feb-2018 08:56
    The Office of Biostatistics in CDER is involved in review and research across all functions, including preclinical and CMC.  However, the bulk of their statisticians are in support of review teams.  CDRH has their own Division of Biostatistics in the Office of Biometrics and Epidemiology.  I have less experience in CBER, but assume they do the same.

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    Glen Park
    Jersey City NJ
    United States
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    Original Message


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