The Use of Patient-Reported Outcome Measures in Phase I Oncology Clinical Trials
- PMID: 33823518
- DOI: 10.1159/000514874
The Use of Patient-Reported Outcome Measures in Phase I Oncology Clinical Trials
Abstract
Objective: To investigate patient-reported outcome (PRO) usage in phase I oncology clinical trials, including types of PRO measures and changes over time.
Methods: We analyzed ClinicalTrials.gov records of phase I oncology clinical trials completed by December 2019.
Results: Of all eligible trials, 2.3% (129/5,515) reported ≥1 PRO, totaling 181 instances of PRO usage. PRO usage increased over time, from 0.6% (trials initiated before 2000) to 3.4% (trials starting between 2015 and 2019). The most common PRO measures were unspecified (29%), tumor-specific (24%), and generic cancer (19%).
Conclusion: Although uncommon in phase I oncology clinical trials, PRO usage is increasing over time. PRO measures were often unspecified on ClinicalTrials.gov, suggesting that more precise reporting and standardization are needed.
Keywords: Cancer; Clinical trials; Oncology; Patient-reported outcomes; Phase I.
© 2021 The Author(s) Published by S. Karger AG, Basel.
Similar articles
-
Inclusion of Patient-Reported Outcomes in Adolescent and Young Adult Phase III Therapeutic Trials: An Analysis of Cancer Clinical Trials Registered on ClinicalTrials.gov.Value Health. 2021 Dec;24(12):1820-1827. doi: 10.1016/j.jval.2021.06.012. Epub 2021 Aug 8. Value Health. 2021. PMID: 34838280 Free PMC article.
-
Rare use of patient-reported outcomes in childhood cancer clinical trials - a systematic review of clinical trial registries.Eur J Cancer. 2021 Jul;152:90-99. doi: 10.1016/j.ejca.2021.04.023. Epub 2021 Jun 2. Eur J Cancer. 2021. PMID: 34090144
-
Trends in patient-reported outcome use in early phase dose-finding oncology trials - an analysis of ClinicalTrials.gov.Cancer Med. 2021 Nov;10(22):7943-7957. doi: 10.1002/cam4.4307. Epub 2021 Oct 22. Cancer Med. 2021. PMID: 34676991 Free PMC article.
-
Inclusion of patient-reported outcome measures in registered clinical trials: Evidence from ClinicalTrials.gov (2007-2013).Contemp Clin Trials. 2015 Jul;43:1-9. doi: 10.1016/j.cct.2015.04.004. Epub 2015 Apr 18. Contemp Clin Trials. 2015. PMID: 25896116
-
Working plan for the use of patient-reported outcome measures in adults with brain tumours: a Response Assessment in Neuro-Oncology (RANO) initiative.Lancet Oncol. 2018 Mar;19(3):e173-e180. doi: 10.1016/S1470-2045(18)30004-4. Lancet Oncol. 2018. PMID: 29508764 Review.
Cited by
-
International Society for Quality of Life Research commentary on the US Food and Drug Administration draft guidance for industry on core patient-reported outcomes in cancer clinical trials.Qual Life Res. 2023 Aug;32(8):2155-2163. doi: 10.1007/s11136-023-03396-z. Epub 2023 May 23. Qual Life Res. 2023. PMID: 37217665 Free PMC article.
-
Patient-reported outcomes in adoptive cell-therapy trials: mind the gap.J Immunother Cancer. 2022 Dec;10(12):e006082. doi: 10.1136/jitc-2022-006082. J Immunother Cancer. 2022. PMID: 36600604 Free PMC article.
-
Health-related quality of life outcomes reporting associated with FDA approvals in haematology and oncology.BMJ Oncol. 2024 Jul 11;3(1):e000369. doi: 10.1136/bmjonc-2024-000369. eCollection 2024. BMJ Oncol. 2024. PMID: 39886148 Free PMC article.
-
Incorporating patient-reported outcomes in dose-finding clinical trials with continuous patient enrollment.J Biopharm Stat. 2023 Jul 26:1-12. doi: 10.1080/10543406.2023.2236216. Online ahead of print. J Biopharm Stat. 2023. PMID: 37496233 Free PMC article.
-
Feasibility of a new electronic patient-reported outcome (ePRO) system for an advanced therapy clinical trial in immune-mediated inflammatory disease (PROmics): protocol for a qualitative feasibility study.BMJ Open. 2022 Sep 6;12(9):e063199. doi: 10.1136/bmjopen-2022-063199. BMJ Open. 2022. PMID: 36691123 Free PMC article.
Publication types
MeSH terms
LinkOut - more resources
Full Text Sources
Other Literature Sources
Medical
