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Abstract Details

Activity Number: 319
Type: Topic Contributed
Date/Time: Tuesday, July 31, 2012 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #305040
Title: Data-Driven Interim Analysis in Clinical Trials
Author(s): Kuang-Kuo Lan*+
Companies: Johnson & Johnson
Address: 920 Route 202, Raritan, NJ, 08869, United States
Keywords: over-running ; under-running

The alpha-spending function approach in clinical trial design requires pre-specification of the maximum information of the study. For budget or other logistic reasons, many trials are designed for maximum duration. Control of alpha becomes a concern when (1) the final maximum value of information is quite different from the pre-specified value, or, (2) the timing and frequency of interim data analysis are data-driven. We will review these two issues and present some existing solutions to minimize potential alpha inflation.

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