Use of patient-reported outcomes to inform symptom and functional outcomes in cancer drug regulatory decisions: challenges and future directions - 29/05/25

Francesco Pignatti ^a , Peter Mol ^{b, c}, Chantal Quinten ^a, Douwe Postmus ^{a, b}, Anja Schiel ^d, Maxime Sasseville ^e, Shun Tezuka ^f, Vishal Bhatnagar ^g, Paul Kluetz ^g

^a European Medicines Agency, Amsterdam, Netherlands 

^b 1083 HS Amsterdam; University Medical Center Groningen, Groningen, Netherlands 

^c Dutch Medicines Evaluation Board, Utrecht, Netherlands 

^d Norwegian Medical Products Agency, Oslo, Norway 

^e Health Canada, Ottawa, ON, Canada 

^f Pharmaceuticals and Medical Devices Agency, Tokyo, Japan 

^g US Food and Drug Administration Oncology Center of Excellence, Silver Spring, MD, USA 

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