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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 Zachary L'Heureux, PhD, MPharm, MSc

      Darryl Zachary L'Heureux, PhD, MPharm, MSc

      • Senior Scientific Writer
      • Bristol-Myers Squibb, United States
      Eileen  Girten, MS

      Eileen Girten, MS

      • Principal Medical Writer
      • PRA Health Sciences, 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

      • WWHERO Oncology Lead
      • Bristol-Myers Squibb, United States
      Ari  Gnanasakthy, MBA, MS, MSc

      Current Issues in the Applications and Interpretation of PRO Data

      Ari Gnanasakthy, MBA, MS, MSc

      • Head, Patient Reported Outcomes
      • Novartis Pharmaceuticals Corporation, United States