61MO Perceptions of healthcare professionals and regulators on the use of real-world data as external comparators in late-stage oncology single-arm trials
Real-world data (RWD) have potential applications for complementing other data sources, including as external comparators for single-arm trials (SAT). We aimed to explore perceptions about this methodology in the setting of advanced cancer of high unmet medical need.
Authors
- Diogo Martins-Branco (ORCID: https://orcid.org/0000-0002-7214-4818)
- Kelly M. Robertson (ORCID: https://orcid.org/0000-0002-0090-8604)
- Francesco Pignatti (ORCID: https://orcid.org/0000-0001-9296-2474)
- Tarec Christoffer E El-Galaly
- D. Di Trapani (ORCID: https://orcid.org/0009-0004-5052-3835)
- Robin Doeswijk
- U-P. Rohr
- G. Pentheroudakis
- Kimmo Porkka (ORCID: https://orcid.org/0000-0003-4112-5902)
- Miriam Koopman (ORCID: https://orcid.org/0000-0003-1550-1978)
- Nathan I. Cherny (ORCID: https://orcid.org/0000-0003-1976-8952)
- Antonios Valachis (ORCID: https://orcid.org/0000-0001-6059-0194)
- Martin Kaiser (ORCID: https://orcid.org/0000-0002-3677-4804)
- Raúl Córdoba (ORCID: https://orcid.org/0000-0002-7654-8836)
- Douwe Postmus (ORCID: https://orcid.org/0000-0002-9458-7038)
- Mario Maio
- Petrus Mol
Institutions
- European Medicines Agency (NL)
- Swissmedic (CH)
- University Medical Center Groningen (NL)
- University of Helsinki (FI)
- European Society for Medical Oncology (CH)
- Group of Eight (AU)
- Shaare Zedek Medical Center (IL)
- Aarhus University Hospital (DK)
- European Hematology Association (NL)
- University Medical Center Utrecht (NL)
- European Renal Association – European Dialysis and Transplant Association (GB)
- Istituto Oncologico Veneto (IT)
- Hospital Universitario Fundación Jiménez Díaz (ES)
- Örebro University Hospital (SE)
- Medicines Evaluation Board (NL)
- Istituti di Ricovero e Cura a Carattere Scientifico (IT)
- University of Turin (IT)
- European Institute of Oncology (IT)
Publication Details
- Journal
- ESMO Open
- Published
- 2025-03-01
- DOI
- https://doi.org/10.1016/j.esmoop.2025.104374
- Primary Topic
- Health Systems, Economic Evaluations, Quality of Life
- Type
- article
- Field-Weighted Citation Impact
- 0.00