Event

Learn how to implement PROMIS in clinical trials and regulatory submissions to support patient-focused drug development.

This short course shows clinical development teams how to implement the Patient-Reported Outcomes Measurement Information System (PROMIS®) in registration trials and regulatory submissions using FDA Patient-Focused Drug Development guidance. Participants will learn regulator-aligned methods that are applicable to other PRO measures, from endpoint selection through labeling claims. The course introduces PROMIS as a comprehensive health assessment system across physical, mental, and social domains, using item response theory (IRT)-based scoring, computer-adaptive testing, digital capabilities, and validation across more than 80 languages.

Technical Topics Include:

• PROMIS domain and measure selection

• Endpoint selection and protocol specification

• Estimands and alignment with regulatory expectations

• Determining meaningful change in PRO outcomes

• Psychometric evaluation and instrument quality assessment

• Digital ePRO implementation and data collection considerations

• Global translation and cross-cultural validation

• Preparing for regulatory review and submission

This Course Includes Tools and Concepts That Can Be Immediately Applied, Including:

• Regulator-aligned frameworks for PRO endpoint and measure selection

• Case-based examples across disease areas

• Practical guidance for protocol development and regulatory defense

• Analysis of successful labeling claims and challenging submissions

• Identification of common pitfalls and critical success factors

Participants will gain practical knowledge and confidence to design PRO strategies using PROMIS®, support regulatory submissions, and apply best practices that extend to other patient-reported outcome measures and real-world evidence and HTA contexts.

LEVEL: Experienced
TRACK: Patient-Centered Research

This short course is offered in-person at the ISPOR 2026 conference. Separate registration is required. Registration coming soon. Visit the ISPOR 2026 Program page to register and learn more.

FACULTY MEMBERS

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.