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Advancing the Science of Study Endpoints


Session 3: When Does a Patient Feel Well and How is this Measured

Session Chair(s)

René  Allard, PhD

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)

René  Allard, PhD

Speaker

René Allard, PhD

  • Contractor
  • CTC, Germany
Acacia  Parks, PhD

When Does a Patient Feel Well and How is this Measured

Acacia Parks, PhD

  • Chief Scientist
  • Happify Health, United States
Joseph V. Pergolizzi, MD

When Does a Patient Feel Well and How is this Measured

Joseph V. Pergolizzi, MD

  • Co-Founder and Chief Operating Officer
  • NEMA Research, Inc., United States

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