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Real World Evidence Conference

How Real World Evidence can be used for regulatory purposes


Session 3: Patient Relevant Outcomes from Drug Development to Clinical Practice

Session Chair(s)

Bart  Barefoot

Bart Barefoot

  • Director, VEO, Real World Evidence Policy and Advocacy
  • GlaxoSmithKline, United Kingdom
Robert  Suruki

Robert Suruki

  • RWE Strategy Lead, Immunology
  • UCB Pharma, Inc., Belgium
Most outcomes (endpoints) used in clinical trials are not designed for sustainable use in clinical practice and do not reflect treatment impact in a larger population over the long term. Focusing on outcomes that matter most to patients, and can be measured in both trials and clinical practice, would support better decision making for individual patients and population-level health. During this session, we will discuss current initiatives that are driving a new approach to more aligned outcome measurement and broader stakeholder input in measure development. We also will highlight use cases of objective outcome measures – including patient-reported outcomes (PROs) and clinician -reported outcomes (ClinROs) – that can be used continuously in trials and clinical practice.

Speaker(s)

Eileen  Mack Thorley, MPH

Speaker

Eileen Mack Thorley, MPH

  • Senior Research Scientist
  • PatientsLikeMe, United States
Donna  Messner, PhD

The Outcomes Landscape

Donna Messner, PhD

  • President and CEO
  • Center for Medical Technology Policy (CMTP), United States
Jean  Rommes, PhD, MS

Patient Perspective

Jean Rommes, PhD, MS

  • Patient Advocate
  • United States

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