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Advancing the Science of Study Endpoints


Session 5: Endpoint Evolution During Drug Development – Exit Interviews to Develop Qualitative Evidence for PRO Assessments and Endpoints

Session Chair(s)

Ashley F. Slagle, PhD, MS

Ashley F. Slagle, PhD, MS

  • Principal, Scientific and Regulatory Consulting
  • Aspen Consulting, LLC, United States
Exit interviews of clinical trial participants are becoming increasingly common. There are a number of goals and objectives that might be met using these types of interviews. One important focus of these interviews is to develop qualitative evidence to support PRO assessments and endpoints in trials, however, there are no standard methods to guide this type of work or how the data might be used. This session is intended to introduce participants to the benefits, considerations, and challenges of using exit interviews to generate qualitative data to develop or support PRO assessments and endpoints. Scientific, operational, and regulatory perspectives will be shared. An overview of the types of goals and objectives that can be achieved using exit interviews, as well as appropriate timing across a drug development program will be discussed. Good methods for exit interviews and suggestions for considering and overcoming operational challenges will be provided. Formal presentations will be followed by a panel discussion and audience questions and answers to ensure important issues surrounding this approach to interviews are covered.
Learning Objective : Summarize benefits and opportunities for the use of exit interviews throughout the different phases of drug development
  • Discuss regulatory recommendations for generating and using data from exit interviews to support PRO assessments and endpoints
  • Describe good practices and methods used to generate informative qualitative data using exit interviews
  • Identify operational challenges that may impact decision-making for exit interviews and consider approaches to manage risks
  • Speaker(s)

    Robyn T. Carson, MPH

    Exit interviews: Benefits, Challenges, and Operational Considerations

    Robyn T. Carson, MPH

    • Vice President, Patient-Centered Outcomes Research
    • AbbVie, United States
    Cheryl D. Coon, PhD

    Qualitative Evidence Generation Using Exit Interviews in Clinical Trials – Good Practices

    Cheryl D. Coon, PhD

    • Principal
    • Outcometrix, United States
    Elektra  Papadopoulos, MD, MPH

    A Regulatory Perspective on Use of Exit Interviews in Clinical Trials to Generate Qualitative Evidence for PRO Assessments and Endpoints

    Elektra Papadopoulos, MD, MPH

    • Deputy Director (acting) Division of Clinical Outcome Assessment, OND, CDER
    • FDA, United States

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