Will I feel better? Raising the bar for quality of life in oncology.
No abstract available
COI Statement
Competing interests: The authors declare no competing interests.
References:
Basch, E. Toward patient-centered drug development in oncology. N. Engl. J. Med. 369, 397–400 (2013).
Kluetz, P. G., O’Connor, D. J. & Soltys, K. Incorporating the patient experience into regulatory decision making in the USA, Europe, and Canada. Lancet Oncol. 19, e267–e274 (2018).
Pe, M. et al. Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI): stakeholder views, objectives, and procedures. Lancet Oncol. 24, e270–e283 (2023).
U.S. Food and Drug Administration. Guidance for industry: core patient-reported outcomes in cancer clinical trials. FDA https://www.fda.gov/regulatory-information/search-fda-guidance-documents/core-patient-reported-outcomes-cancer-clinical-trials (accessed 7 February 2025).
Cherny, N. I. et al. ESMO-Magnitude of Clinical Benefit Scale version 1.1. Ann. Oncol. 28, 2340–2366 (2017).