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Hyatt Regency Cambridge

Nov 14, 2019 7:30 AM - Nov 15, 2019 12:30 PM

575 Memorial Drive, Cambridge, MA 02139

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, JD

Bart Barefoot, JD

Head, Europe Regulatory Policy

GSK, 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.


Eileen  Mack Thorley, MPH


Eileen Mack Thorley, MPH

PatientsLikeMe, United States

Senior Research Scientist

Donna  Messner, PhD

The Outcomes Landscape

Donna Messner, PhD

Center for Medical Technology Policy (CMTP), United States

President and CEO

Jean  Rommes, PhD, MS

Patient Perspective

Jean Rommes, PhD, MS

United States

Patient Advocate

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