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Omni Rancho Las Palmas Resort & Spa

19 mar 2018 1:00 p.m. - 21 mar 2018 4:00 p.m.

41000 Bob Hope Drive, Rancho Mirage, CA 92270

Medical Affairs and Scientific Communications Forum

Medical Communication, MSL, and Medical Writing.

Session 11 Track 2A: Understanding Patient-Reported Outcomes (PROs) in Clinical Trials: The Value of Patient Experience

Session Chair(s)

Darryl  L'Heureux, PhD, MPharm, MSc

Darryl L'Heureux, PhD, MPharm, MSc

Director, Clinical Science, Medical Writing, and Publications

Ambrx, Inc, United States

Eileen  Girten, MS

Eileen Girten, MS

Director, Medical Writing

Pfizer Inc, United States

There is a growing focus on placing patients at the center of clinical research, and while medical technology allows for the assessment of many outcomes, there are some data that can only be obtained directly from the patient. Patient-reported outcomes (PROs) are reports of feelings and functioning that come directly from the patient without interpretation by a caregiver, treating physician, or anyone else. Patients’ reports of how they feel and function can be useful in assessing the burden of disease, treatment response, and in guiding clinician, payer, and policy decision-making. This session will provide an introduction to PRO assessment, its role in the context of clinical trials, and emerging issues given evolving regulatory and payer landscapes.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Differentiate PROs from other clinical outcomes and discuss the importance of their assessment
  • Identify relevant considerations for collecting and evaluating PRO data
  • Understand current issues regarding uses of PRO data for regulatory and payer applications

Speaker(s)

Gregory  Maglinte

An Introduction to PRO Assessment

Gregory Maglinte

Bristol-Myers Squibb, United States

WWHERO Oncology Lead

Ari  Gnanasakthy, MBA, MS, MSc

Current Issues in the Applications and Interpretation of PRO Data

Ari Gnanasakthy, MBA, MS, MSc

Novartis Pharmaceuticals Corporation, United States

Head, Patient Reported Outcomes

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