Abstract
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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1543-1548 |
| Number of pages | 6 |
| Journal | Value in Health |
| Volume | 26 |
| Issue number | 10 |
| DOIs | |
| State | Published - Oct 2023 |
Funding
Funding/Support: No funding was received for this work, in-kind support was provided by the Critical Path Institute. Conflict of Interest Disclosures: Dr King-Kallimanis reports grants from AstraZeneca , G1 Therapeutics, Bristol-Myers Squibb , Merck , BluePrint Medicine, Eli Lilly , Genentech , Takeda , Jazz Pharmaceuticals , other (consulting fees) from Eli Lily, Health Outcome Solutions, University of South Florida , Atheneum, other (advisory boards) from Bristol-Myers Squibb , Association of Community Cancer Centers, outside the submitted work. Dr Calvert is Director of the Birmingham Health Partners Centre for Regulatory Science and Innovation, Director of the Centre for Patient-Reported Outcomes Research and is a National Institute for Health and Care Research (NIHR) Senior Investigator. She receives funding from the NIHR Birmingham Biomedical Research Centre , the NIHR Surgical Reconstruction and Microbiology Research Centre , NIHR Applied Research Collaboration (ARC) West Midlands at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust , NIHR Birmingham-Oxford Blood and Transplant Research Unit in Precision Transplant and Cellular Therapeutics, University of Birmingham , UK, Health Data Research UK, Innovate UK, UK Research and Innovation, SPINE UK, Macmillan Cancer Support, UCB, and GSK. Dr Calvert has received personal fees from Aparito Ltd, Astellas, Takeda, Merck, Daiichi Sankyo, Glaukos, CIS Oncology, GlaxoSmithKline , Genentech , and the Patient-Centered Outcomes Research Institute outside of the submitted work. Dr. Cella has nothing to disclose. Dr Coens reports employment at EORTC HQ, during the conduct of the study. Dr Cocks reports employment from Adelphi Values, outside the submitted work. Dr Jonsson has nothing to disclose. Dr Mahendraratnam is an employee and holds stock options at Aetion Inc. Dr Mahendraratnam is also a Steering Committee Member on the Digital Medicine Society (DiMe) Digital Health Measurement Collaborative Community. The views discussed in the article reflect the views of the author. Dr. Fairclough has nothing to disclose. Ms Maues has nothing to disclose. Dr. Sarac has nothing to disclose. Dr Shaw reports being an employee and shareholder of Bristol-Myers Squibb. Ms. Stigger has nothing to disclose. Dr Trask is employed at Genentech and holds stock in Roche. The views expressed are those of the author(s) and not necessarily those of the Food and Drug Administration, National Institute for Health and Care Excellence, National Health Services, the NIHR, or the Department of Health and Social Care. No other disclosures were reported.
Keywords
- clinical trials
- multistakeholder perspective
- oncology
- patient-reported outcomes
ASJC Scopus subject areas
- Public Health, Environmental and Occupational Health
- Health Policy
