Abstract #301204

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JSM 2003 Abstract #301204
Activity Number: 129
Type: Contributed
Date/Time: Monday, August 4, 2003 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #301204
Title: A Discussion of Clinical Outcome Assessment Development
Author(s): Jingyu Liu*+ and Catherine Turkel and Thomas Lin
Companies: Allergan Pharmaceuticals and Allergan Pharmaceuticals and Allergan Pharmaceuticals
Address: 2525 Dupont Dr., Irvine, CA, 92623,
Keywords: clinical outcome ; assessment scale ; interrater reliability ; intrarater reliability ; validity ; factor analysis
Abstract:

In the current regulatory environment, use of clinically meaningful, valid and reliable clinical outcome measurements is a necessity for evaluating efficacy of new drugs or biologics. Developing acceptable clinical assessments is a challenge within the pharmaceutical industry. This presentation will discuss procedures that can be used in developing a clinical outcome assessment, with a focus on the statistical aspects of the development. Statistical methodology will be discussed, as will details of an actual clinical study designed to develop a new clinical measurement.


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