JSM2025
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Topic-Contributed Paper Session

Standardizing Patient-reported Outcome in Oncology: Improving Cancer Care Through Patient Experience

Mon, Aug 4, 8:30 AM - 10:20 AM Room CC-208A Music City Center
Satrajit RoychoudhuryOrganizerMadeline PeOrganizerJoseph CappelleriChair
Biopharmaceutical Section co: Health Policy Statistics Sectionco: Ad Hoc Good Clinical Practices Committee Applied

3 Presentations

From objectives to meaningful results: the pivotal role of estimands in analyzing patient reported outcomes data from randomized cancer clinical trials
8:35 AM - 8:55 AM
Paul Cislo (Pfizer)
Co-authors: Corneel Coens (European Organization for Research and Treatment of Cancer (EORTC)), Paul Cislo (Pfizer)
randomized clinical trialpatient-reported outcomeestimandstandardscancer
Going beyond statistical significance: Is the estimate for the PRO findings clinically meaningful?
8:55 AM - 9:15 AM
Kim Cocks (Adelphi Values)
Co-authors: Kim Cocks (Adelphi Values), Johannes M Giesinger (Medical University of Innsbruck)
Patient Reported Outcomes in Single-arm Trials: Recommendations for the Design and Analysis
9:15 AM - 9:35 AM
Doranne Thomassen (Leiden University Medical Center)
Co-authors: Saskia Le Cessie (Leiden University Medical Center), Doranne Thomassen (Leiden University Medical Center), Satrajit Roychoudhury (Pfizer Inc.)

Discussants

Flora Mulkey (FDA)
Geert Molenberghs (Universiteit Hasselt & Katholieke Universiteit Leuven)
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