Discussion: View Thread

  • 1.  Enrollment over-run

    Posted 05-26-2023 22:54

    Enrollment in a clinical trial often continues while data from an interim analysis are being performed, often referred to as enrollment over-run. Although any of us have encountered this, I need a reference for a client. Does anyone know of a reference? 



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    David Bristol
    Statistical Consulting Services, Inc.
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  • 2.  RE: Enrollment over-run

    Posted 05-27-2023 05:30

    Here are three references.
    Two classical ones:
    Whitehead. Overrunning and underrunning in sequential clinical trials. Controlled Clinical Trials (1992) 13:106-121;
    Jennison, Turnbull. Interim analyses: the repeated confidence interval approach. Journal of the Royal Statistical Soc Ser B (Methodological) (1989) 51:305-61;
    and a more recent one:
    Baldi et al. Overrunning in clinical trials: some thoughts from a methodological view. Trials (2020) 21:668.

    Hope this helps,



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    Gerhart Graupner MD ScD
    Graupner Consulting Services
    San Diego, CA
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  • 3.  RE: Enrollment over-run

    Posted 05-27-2023 05:48

    The correct title of the third reference is:
    Overrunning in clinical trials: some thoughts from a methodological review.



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    Gerhart Graupner MD ScD
    Graupner Consulting Services
    San Diego, CA
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