JSM 2004 Online Program

Abstract #302231

This is the preliminary program for the 2004 Joint Statistical Meetings in Toronto, Canada. 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, 2004); 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:	235
Type:	Luncheons
Date/Time:	Tuesday, August 10, 2004 : 12:30 PM to 1:50 PM
Sponsor:	Biopharmaceutical Section
Abstract - #302231
Title:	Issues in Doing Clinical Trials with Small Populations - SOLD OUT
Author(s):	Jessica Kim*+
Companies:	U.S. Food and Drug Administration
Address:	1401 Rockville Pike, Rockville, MD, 20852,
Keywords:
Abstract:	In many clinical trials, the study population can be relatively small. This may bring issues and concerns in analyzing and interpreting the data. It is particularly true when we are dealing with drug development for a rare/serious disease. Topics we will discuss include the importance of defining and measuring endpoints, maintaining a high compliance rate, and developing a pre-specified outcome for sample size determination. We may also discuss the importance of randomization and use of historical controls in studies with limited data availability.

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