Perspectives on Patient-Reported Outcome Data After Treatment Discontinuation in Cancer Clinical Trials.

Autor: King-Kallimanis BL; LUNGevity Foundation, Bethesda, MD, USA. Electronic address: bking-kallimanis@lungevity.org., Calvert M; Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, England, UK; Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, England, UK; National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre, University of Birmingham, Birmingham, England, UK; NIHR Applied Research Collaboration (ARC) West Midlands, University of Birmingham, Birmingham, England, UK; Health Data Research UK, London, England, UK; NIHR Birmingham-Oxford Blood and Transplant Research Unit in Precision Transplant and Cellular Therapeutics, University of Birmingham, UK., Cella D; Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL, USA., Cocks K; Adelphi Values, Cheshire, England, UK., Coens C; Quality of Life Department, EORTC HQ, Brussels, Belgium., Fairclough D; Colorado School of Public Health, Aurora, CO, USA., Howie L; Pardee Cancer Center, Hendersonville, NC, USA., Jonsson P; Data and Analytics, National Institute for Health and Care Excellence (NICE), Manchester, UK., Mahendraratnam N; Aetion, Inc New York, NY, USA., Maues J; Patient Advocate/GRASP, Baltimore, MA, USA., Sarac S; Member of CHMP (EMA), Danish Medicines Agency, Copenhagen, Denmark., Shaw J; Bristol-Myers Squibb, Lawrenceville, NJ, USA., Stigger N; Patient Advocate, Chicago, IL, USA., Trask P; Genentech, Inc, South San Francisco, CA, USA., Wieseler B; Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, Germany.
Jazyk: angličtina
Zdroj: Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research [Value Health] 2023 Oct; Vol. 26 (10), pp. 1543-1548. Date of Electronic Publication: 2023 Jul 06.
DOI: 10.1016/j.jval.2023.06.019
Abstrakt: Objectives: Patient-reported outcome (PRO) data are critical in understanding treatments from the patient perspective in cancer clinical trials. The potential benefits and methodological approaches to the collection of PRO data after treatment discontinuation (eg, because of progressive disease or unacceptable drug toxicity) are less clear. The purpose of this article is to describe the Food and Drug Administration's Oncology Center of Excellence and the Critical Path Institute cosponsored 2-hour virtual roundtable, held in 2020, to discuss this specific issue.
Methods: We summarize key points from this discussion with 16 stakeholders representing academia, clinical practice, patients, international regulatory agencies, health technology assessment bodies/payers, industry, and PRO instrument development.
Results: Stakeholders recognized that any PRO data collection after treatment discontinuation should have clearly defined objectives to ensure that data can be analyzed and reported.
Conclusions: Data collection after discontinuation without a justification for its use wastes patients' time and effort and is unethical.
(Copyright © 2023. Published by Elsevier Inc.)
Databáze: MEDLINE
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