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Biostatistics Industry and Regulator Forum


Session 5: The Use of Patient Experience Data to Inform Benefit- From Instrument to Label Claim

    Session Chair(s)
      Jonathan  Haddad, MPH

      Jonathan Haddad, MPH

      • Director, Clinical Statistics
      • GlaxoSmithKline, United States
      Representative Invited

      Representative Invited

      • FDA, United States
    This session will cover the development and use of patient experience data under the framework established by the 21st Century Cures Act. Through the use of examples, speakers will examine the steps and requirements to establish usable patient experience endpoints and examine how these data are analyzed and used to inform the benefit-risk assessment in the US drug approval and labeling process.
    Learning Objective :

    At the conclusion of this session, participants should be able to:

    • Understand the role of the 21st Century Cures Act in enabling the inclusion of patient experience endpoints in drug development
    • Gain awareness of the process for identifying and developing measures of patient experience
    • Understand the role of COA office in regulatory acceptance of patient experience endpoints
    • Gain insight of how these data are evaluated in the FDA review process

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Submission Deadline: February 12