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Abstract Details

Activity Number: 530
Type: Roundtables
Date/Time: Wednesday, August 1, 2012 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #306520
Title: Design a Clinical Trial: Sequential Design or Fixed Sample Size Design?
Author(s): Judy Li*+
Companies: FDA
Address: 7500 Standish Place, Rockville, MD, 20855, United States
Keywords: Sequential Design ; Fixed Sample Size Design ; Clinical Trial
Abstract:

In sequential design of experiment, the samples size of the study is not fixed in advance but is a function of the observations themselves. The advantage of sequential design over fixed size sampling is that in some circumstances the probability of erroneous decision could be reduced to a desired low level by reaching a decision faster. However, sequential design has its own issues and problems. The roundtable discussion is going to compare the pros and cons of both sequential design and fixed sample size design, and discuss the possible different clinical trial scenarios under which one design is preferable over the other.


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