Assessment of Patient-Reported Outcomes in Industry-Sponsored Phase I Oncology Studies: Considerations for Translating Theory Into Practice
Oct 1, 2023, 00:00 AM
10.1016/j.jval.2023.06.006
https://www.valueinhealthjournal.com/article/S1098-3015(23)03021-8/fulltext
Section Title :
COMMENTARY
Section Order :
1440
First Page :
1440
An increasing interest in the identification of optimal dosage for oncology therapies has prompted key opinion leaders and regulators to encourage the integration of patient-reported outcome (PRO) assessments in phase I oncology clinical trials. Although the potential benefits of assessing PROs in early-phase studies have been acknowledged, the difficulties that arise from such a radical shift have been largely overlooked in the public discussion. In this commentary, the authors provide insight into the challenges that industry sponsors face in integrating PRO assessments into phase I oncology trials, with the ultimate goal of facilitating conversations that may help to resolve some of these issues.
https://www.valueinhealthjournal.com/action/showCitFormats?pii=S1098-3015(23)03021-8&doi=10.1016/j.jval.2023.06.006
HEOR Topics :
- Clinical Trials
- Patient-Centered Research
- Patient-reported Outcomes & Quality of Life Outcomes
- Rare & Orphan Diseases
- Specific Diseases & Conditions
- Study Approaches