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. 2025 Jun;26(6):687-690.
doi: 10.1016/S1470-2045(25)00150-0. Epub 2025 Apr 14.

Using patient-reported outcomes and health-related quality of life data in regulatory decisions on cancer treatment: highlights from an EMA-EORTC workshop

Madeline Pe  1 , Caroline Voltz-Girolt  2 , Jill Bell  3 , Vishal Bhatnagar  4 , Jan Bogaerts  5 , Christopher Booth  6 , Juan Garcia Burgos  2 , Joseph C Cappelleri  7 , Corneel Coens  5 , Pierre Demolis  8 , Harald Enzmann  9 , Johannes M Giesinger  10 , Alexandra Gilbert  11 , Mogens Groenvold  12 , Paul Kluetz  4 , Claire Piccinin  5 , Douwe Postmus  13 , Chantal Quinten  2 , Bettina Ryll  14 , Maxime Sasseville  15 , Michael Schlichting  16 , Hans Schuerer  17 , Anja Schiel  18 , James W Shaw  19 , Ashley Wilder Smith  20 , Shun Tezuka  21 , Carla Torre  22 , Winette T A van der Graaf  23 , Beate Wieseler  24 , Friedrich Wittenbecher  25 , Jaap C Reijneveld  26 , Peter Mol  13
Affiliations

Using patient-reported outcomes and health-related quality of life data in regulatory decisions on cancer treatment: highlights from an EMA-EORTC workshop

Madeline Pe et al. Lancet Oncol. 2025 Jun.

Erratum in

No abstract available

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Conflict of interest statement

MP, CV-G, PD, JBo, JR, and PM conceptualised and developed the agenda. MP developed the outline of the initial draft. MP and CV-G led in the writing of the paper with a review by PM. All authors were chairs, presenters or panellists in the workshop, which provided the content of the commentary. All authors read and contributed to the revisions. All authors approved the final draft of the commentary. We gratefully acknowledge Francesco Pignatti (EMA) and Denis Lacombe (EORTC) for initiating discussions that led to the development of this workshop. We sincerely appreciate their valuable feedback during the writing of this commentary. The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the regulatory agencies or organisations with which the authors are employed or affiliated. MSc reports holding shares with Merck KGaA. JWS reports leadership position with EUonQOL, was a shareholder with Bristol Myers Squibb. WTAvdG reports receiving grants from Eli Lilly paid to her institute, participated in Advisory boards for PTC Therapeutics and Agenus, all paid to her institute, and is the EORTC president and is a board member of the European Cancer Organisation, all unpaid. JBe reports stock or stock options with AZ pharmaceuticals and is involved with Evinova which is a separate health tech business within AZ. JCC reports holding stock options with Pfizer. All other authors reported no conflicts of interest.

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