PRO Measures: Development and Use in Clinical Research

Patients, providers, payers, and regulators increasingly demand evidence that new health care interventions make a real difference to people’s lives. Patient-reported outcome (PRO) data are critical for demonstrating the impact of interventions on how a patient feels and functions.

Patient-reported outcomes (e.g., fatigue, pain, physical functioning, social functioning) can provide great value to research but can present significant challenges. This course provides students with the knowledge necessary to incorporate PROs into clinical research. Students will learn the different types and suitability of measures, methods for developing new measures, and best practices for collecting and analyzing PROs in clinical trials. The course will include a friendly introduction to the technical aspects of Classical Test Theory and Item Response Theory for the evaluation of the psychometric properties of a PRO measure. This course incorporates recommendations from the FDA and other regulatory bodies in the design and application of PRO measures in clinical research.

Who should Attend:

  • Those who lead clinical development programs and need to understand the role of PROs in those programs
  • Those who wish to develop new PRO measures or adapt existing PRO measures.
  • Those who use PRO measures in clinical research that informs clinical decision making and/or reimbursement
  • Those who fund or sponsor the development and analysis of PRO measures

How you’ll benefit:

  • Learn how PROs are conceptualized, developed, evaluated, and used most effectively in clinical research.
  • Engage with renowned experts in the field.
  • Network with colleagues, collaborators, and clients.
  • Share experiences, ideas, and developments in an open, engaging environment.
  • Advance your career by participating in an ISPOR In-Person Training Program.
  • Stay current on theoretical and methodological developments in PRO assessment.