May 13, 2025
Mastering Patient-Reported Outcomes (PRO) in Drug Development
Gain the expertise to successfully implement patient-reported outcomes (PRO) measurement within drug development programs to generate patient-centered value messages. A well-formulated PRO strategy is critical for navigating regulatory, reimbursement, and market access challenges, requiring an understanding of instrument selection, psychometric evaluation, data capture, and interpretation.
Technical Topics Include:
- PRO instrument selection: Assessing quality and appropriateness
- Psychometric evaluation: Understanding validity, reliability, and responsiveness
- Regulatory expectations: Qualitative and quantitative evidence required for approval
- Data capture & interpretation: Strategies for meaningful measurement in clinical trials
- Determining the need for new instruments: When and how to develop new PRO tools
- Common pitfalls & success stories: Learning from real-world PRO implementation cases
This Course Includes Tools and Concepts That Can Be Immediately Applied, Including:
- Practical guidance on reviewing and selecting PRO measures
- Best practices for data collection, interpretation, and regulatory submission
- Interactive discussions on PRO implementation challenges and solutions
- Strategies for meaningful change interpretation to support clinical trial outcomes
PREREQUISITE: This course assumes that participants will have a basic knowledge of key PRO-related concepts (eg, health-related quality of life, symptoms, impacts, a general knowledge of the PRO development steps, and a working knowledge of PRO measurement within clinical programs.)
LEVEL: Advanced
TRACK: Patient-Centered Research
This short course is offered in-person at the ISPOR 2025 conference. Separate registration is required. Visit the ISPOR 2025 Program page to register and learn more.
FACULTY MEMBERS
Schedule:
LENGTH: 4 Hours | Course runs 1 day
Sunday, 13 May 2025 | Course runs 1 Day
8:00am-12:00pm Eastern Daylight Time (EDT)
ISPOR short courses are designed to enhance knowledge and techniques in core health economics and outcomes research (HEOR) topics as well as emerging trends in the field. Short courses offer 4 or 8 hours of premium scientific education and an electronic course book. Active attendee participation combined with our expert faculty creates an immersive and impactful learning experience. Short courses are not recorded and are only available during the live course presentation.