JSM Preliminary Online Program
This is the preliminary program for the 2007 Joint Statistical Meetings in Salt Lake City, Utah.

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Activity Number: 119
Type: Invited
Date/Time: Monday, July 30, 2007 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #307978
Title: Assessment of Safety Data in a New Drug Development Program: Some Points to Consider
Author(s): Weichung J. Shih*+ and Hui Quan
Companies: University of Medicine and Dentistry of New Jersey and sanofi-aventis
Address: School of Public Health, 16 Ambrose Valley Lane, Piscataway, NJ, 08854,
Keywords: Intention-To-Treat ; Treatment Emergent Adverse Event ; Data Monitoring ; off-drug period
Abstract:

Assessment of safety information in a new drug development program should be equally, if not more, important as the efficacy assessment. However, when designing a clinical trial, especially in the later phases (IIB and III), including sample size calculation and methods of evaluation, attention is usually paid more on the efficacy more than the safety side. Although a later phase study is usually regarded as a confirmatory trial by the regulatory authority, we argue that for safety analyses, it is more appropriate to emphasize their exploratory nature. In this talk we will highlight several essential points to consider along this general line.

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Revised September, 2007