JSM 2003 Online Program

Abstract #300231

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Activity Number:	57
Type:	Contributed
Date/Time:	Sunday, August 3, 2003 : 4:00 PM to 5:50 PM
Sponsor:	Biopharmaceutical Section
Abstract - #300231
Title:	Quality of Life Endpoint in Oncology Drug Trials--Issues and Statistical Modeling
Author(s):	Rajeshwari Sridhara*+ and Gang Chen and George Y.H. Chi
Companies:	Food and Drug Administration and Food and Drug Administration and Food and Drug Administration
Address:	3943 White Rose Way, Ellicott City, MD, 21042-5801,
Keywords:	QOL ; oncology trials
Abstract:	The utilization of quality of life (QOL) outcomes to support the efficacy claim in the development of oncology drugs is often questionable. Major issues when using QOL endpoints in oncology drug trials include trials with no placebo control, missing data, multiple scores and comparisons, and the interpretation of efficacy claim, etc. In this presentation the statistical and regulatory impact of these issues on the efficacy claim with respect to QOL outcomes based on oncology drug trials will be discussed.

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