Speakers
David Cella, PhD, Northwestern University, Chicago, IL, United States; Maja Kuharic, PhD, Northwestern University Feinberg School of Medicine, CHICAGO, IL, United States; Xiaodan Tang, PhD, Northwestern University, Chicago, IL, United States; Heather Gelhorn, PhD, PPD Evidera Patient-Centered Research, Thermo Fisher Scientific, Winter Park, CO, United States; Selena Daniels, PharmD, PhD, US Food and Drug Administration, Silver Spring, MD, United States
Separate registration required.
This short course shows clinical development teams how to implement PROMIS® (Patient-Reported Outcomes Measurement Information System) in registration trials and regulatory submissions, using FDA Patient-Focused Drug Development guidance. Participants learn regulator-aligned methods applicable to other PRO measures, from endpoint selection to labeling claims. PROMIS provides comprehensive health assessment across physical, mental, and social domains using IRT-based scoring, computer-adaptive testing, digital capabilities, and validation across 80+ languages. The course covers domain/measure selection, protocol specification, estimands, meaningful change determination, psychometric evaluation, digital ePRO implementation, global translations, and regulatory review preparation. Interactive case-based learning uses real disease examples to guide participants through endpoint selection, protocol development, and regulatory defense. Faculty analyze successful label claims and challenging submissions to identify critical success factors and common pitfalls applicable across PRO instruments, including real-world evidence and HTA applications. A laptop is recommended for interactive exercises and accessing online resources.
PREREQUISITES: Participants should have basic familiarity with clinical trials and patient-reported outcomes, clinical trial design and regulatory processes. Prior PROMIS® knowledge is not required.
Topic
Patient-Centered Research