JSM 2005 Online Program

Abstract #304087

This is the preliminary program for the 2005 Joint Statistical Meetings in Minneapolis, Minnesota. Currently included in this program is the "technical" program, schedule of invited, topic contributed, regular contributed and poster sessions; Continuing Education courses (August 7-10, 2005); and Committee and Business Meetings. This on-line program will be updated frequently to reflect the most current revisions.

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Activity Number:	257
Type:	Topic Contributed
Date/Time:	Tuesday, August 9, 2005 : 10:30 AM to 12:20 PM
Sponsor:	Biopharmaceutical Section
Abstract - #304087
Title:	Comparison of Two Randomized Experimental Designs
Author(s):	Kyunghee Song*+ and Kyung Lee
Companies:	U.S. Food and Drug Administration and U.S. Food and Drug Administration
Address:	1350 Piccard Drive, Rockville, MD, 20850, United States
Keywords:	clinical trials ; randomized block design ; completely randomized design
Abstract:	In clinical trials, the randomized experimental design and the completely randomized design are two widely used designs to evaluate safety and effectiveness. Linear model is commonly used for these designs. In the randomized block design, the experimental units within a block need to be as homogeneous as possible. Therefore, the statistical inference with respect to the treatment effects would be better without using blocking factors. In this study, we want to examine how the choice of the experimental design affects the statistical inference. Especially, we want to examine the statistical inference with different numbers of subjects under two experimental designs. In order to evaluate the statistical performance, a series of simulations will be conducted for small and moderate sample sizes. This presentation, augmented with example, will focus on the current practice in medical device submissions.

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