Why Should You Attend: 
 
Health related quality of life (HRQOL) research is designed to measure patients’ input into the effects of disease and/or treatment and possibly to distinguish between treatments or devices; however it is fundamentally different than traditional medical assessments. HRQOL is not efficacy or safety, yet it can provide an alternative and valuable medical insight.
This webinar presents an introduction to HRQOL that will crystallize knowledge of underlying concepts, strategies, and processes; it will facilitate the attendees’ ability to be conversant, to assist in planning studies, and to avoid common mistakes. Additionally, it is designed to allow for accurate interpretation of HRQOL results and increase the probability of research success. Also, the FDA regulatory implications for PROs will be discussed.
Areas Covered in the Seminar:

• Defining health-related quality of life (HRQOL).
• FDA Guidance.
• Labeling/Package Insert Issues: US and EU.
• Why do HRQOL research?.
• Generic vs disease-specific instruments.
• Examples of questions and questionnaires.
• Scoring questionnaires.
• Psychometric properties - reliability/reproducibility, validity, and responsiveness.
• When to do HRQOL in the drug development process.
• Monitoring issues.
• Statistical issues.
• Proper placement in the protocol and study report.
• References/Bibliography.

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