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Session 3: When Does a Patient Feel Well and How is this Measured
Session Chair(s)
René Allard, PhD
Contractor
CTC, Germany
The clinical studies section of a product’s labeling must discuss those clinical studies that facilitate an understanding of how to use the drug safely and effectively. Moreover, the characteristics that are important for understanding how to interpret and apply the study results of the study population should be described. In the 2018 “World Happiness Report”, three emerging health problems that threaten happiness were identified by Gallup. The collection of “Quality of Life” data has become routine in clinical trials. Would a “Johari window” type risk approach be pertinent to analyze endpoint objectives in clinical trials and real world evidence collection? Should positive emotional behavioral aspects be introduced to better understand endpoints as being part of a holistic outcome approach?
Learning Objective : - Appraise whether there should also be a focus on “positive rating scales measures” in study design such as happiness and well-being as part of understanding of how to use the treatment effectively
- Discriminate between personal individual achievable targets viewing the patient’s holistically and in context with trial related endpoints
- Identify whether routine daily pressures and emotions impact obvious endpoint assessments
Speaker(s)
Speaker
René Allard, PhD
CTC, Germany
Contractor
When Does a Patient Feel Well and How is this Measured
Acacia Parks, PhD
Happify Health, United States
Chief Scientist
When Does a Patient Feel Well and How is this Measured
Joseph V. Pergolizzi, MD
NEMA Research, Inc., United States
Co-Founder and Chief Operating Officer