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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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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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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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Original Message:
Sent: 05-27-2023 05:30
From: Gerhart Graupner
Subject: Enrollment over-run

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,

------------------------------
Gerhart Graupner MD ScD
Graupner Consulting Services
San Diego, CA
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