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Title
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Design and Analysis of Quality of Life Studies in Clinical Trials
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Date / Time / Room
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Sponsor
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Type
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08/10/2002
8:00 AM -
4:00 PM
Room: H-Nassau Suite A
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ASA, Biopharmaceutical Section*
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Other
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Organizer:
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n/a
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Chair:
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n/a
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CE Presenter
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Diane L. Fairclough - University of Colorado Health Sciences Center
Diane L. Fairclough - University of Colorado Health Sciences Center
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Description
Assessment of health-related quality of life (HRQOL) is being incorporated into clinical trial with increasing frequency. As a result, statisticians are being asked to collaborate in the design, conduct, analysis and reporting of these trials. This course is intended to answer the following questions: 1) What exactly is HRQOL and how does it differ from other patient reported outcomes? 2) What are the similarities and differences between HRQOL and other traditional clinical trial endpoints? 3) What are the specific issues in the design, conduct, analysis and reporting of studies with HRQOL assessment? The course will include hands-on experience with several instruments used to assess HRQOL and illustrations of specific concepts using data from actual clinical trials. In addition, students will be expected to participate by suggesting solutions to hypothetical situations designed to illustrate the concepts. The participants are expected to be familiar with 1) basic issues of the design and analysis of clinical trials, and 2) basic techniques for the analysis of repeated measures and longitudinal studies including MANOVA, growth curve and mixed effects modes.
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