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Bethesda North Marriott Hotel and Conference Center

2018年4月23日 (月) 午後 1:00 - 2018年4月25日 (水) 午後 4:15

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

DIA/FDA 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

HIV Disease Area Head, Clinical Statistics

GlaxoSmithKline, United States

Scott  Komo, DrPH

Scott Komo, DrPH

Lead Mathematical Statistician, Office of Translational Sciences, CDER

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

Speaker(s)

Telba  Irony, PhD, MS, MSc

Incorporating Patient Preferences into Regulatory Decision-Making

Telba Irony, PhD, MS, MSc

Janssen R&D, United States

Senior Scientific Director, Quantitative Sciences

Josephine  Park, MBA, MPH

Characterizing Patient Experience Endpoints with Patient Reported Outcomes

Josephine Park, MBA, MPH

GlaxoSmithKline, United States

Director, Patient Reported Outcomes

Laura Lee  Johnson, PhD

Panelist

Laura Lee Johnson, PhD

FDA, United States

Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER

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