Trends in patient‐reported outcome use in early phase dose‐finding oncology trials – an analysis of ClinicalTrials.gov

ABSTRACT Background Patient‐reported adverse events (AEs) may be a useful adjunct to clinician‐assessed AEs for assessing tolerability in early phase, dose‐finding oncology trials (DFOTs). We reviewed DFOTs on ClinicalTrials.gov to describe trends in patient‐reported outcome (PRO) use. Methods DFOTs...

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Autores principales:	Julia Lai‐Kwon, Zhulin Yin, Anna Minchom, Christina Yap
Formato:	article
Lenguaje:	EN
Publicado:	Wiley 2021
Materias:	clinical trials drug development oncology patient‐reported outcomes phase 1 quality of life Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/a51234f7e1fc4d6a9aa857b6e3ea186e
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spelling	oai:doaj.org-article:a51234f7e1fc4d6a9aa857b6e3ea186e2021-11-22T09:08:47ZTrends in patient‐reported outcome use in early phase dose‐finding oncology trials – an analysis of ClinicalTrials.gov2045-763410.1002/cam4.4307https://doaj.org/article/a51234f7e1fc4d6a9aa857b6e3ea186e2021-11-01T00:00:00Zhttps://doi.org/10.1002/cam4.4307https://doaj.org/toc/2045-7634ABSTRACT Background Patient‐reported adverse events (AEs) may be a useful adjunct to clinician‐assessed AEs for assessing tolerability in early phase, dose‐finding oncology trials (DFOTs). We reviewed DFOTs on ClinicalTrials.gov to describe trends in patient‐reported outcome (PRO) use. Methods DFOTs commencing 01 January 2007 – 20 January 2020 with ‘PROs’ or ‘quality of life’ as an outcome were extracted and inclusion criteria confirmed. Study and PRO characteristics were extracted. Completed trials that reported PRO outcomes and published manuscripts on ClinicalTrials.gov were identified, and PRO reporting details were extracted. Results 5.3% (548/10 372) DFOTs included PROs as an outcome. 231 (42.2%) were eligible: adult (224, 97%), solid tumour (175, 75.8%), and seamless phase 1/2 (108, 46.8%). PRO endpoints were identified in more trials (2.3 increase/year, 95% CI: 1.6–2.9) from an increasing variety of countries (0.7/year) (95% CI: 0.4–0.9) over time. PROs were typically secondary endpoints (207, 89.6%). 15/77 (19.5%) completed trials reported results on the ClinicalTrials.gov results database, and of those eight included their PRO results. Eighteen trials had published manuscripts available on ClinicalTrials.gov. Three (16.7%) used PROs to confirm the maximum tolerated dose. No trials identified who completed the PROs or how PROs were collected. Conclusions PRO use in DFOT has increased but remains limited. Future work should explore the role of PROs in DFOT and determine what guidelines are needed to standardise PRO use.Julia Lai‐KwonZhulin YinAnna MinchomChristina YapWileyarticleclinical trialsdrug developmentoncologypatient‐reported outcomesphase 1quality of lifeNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENCancer Medicine, Vol 10, Iss 22, Pp 7943-7957 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	clinical trials drug development oncology patient‐reported outcomes phase 1 quality of life Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	clinical trials drug development oncology patient‐reported outcomes phase 1 quality of life Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Julia Lai‐Kwon Zhulin Yin Anna Minchom Christina Yap Trends in patient‐reported outcome use in early phase dose‐finding oncology trials – an analysis of ClinicalTrials.gov
description	ABSTRACT Background Patient‐reported adverse events (AEs) may be a useful adjunct to clinician‐assessed AEs for assessing tolerability in early phase, dose‐finding oncology trials (DFOTs). We reviewed DFOTs on ClinicalTrials.gov to describe trends in patient‐reported outcome (PRO) use. Methods DFOTs commencing 01 January 2007 – 20 January 2020 with ‘PROs’ or ‘quality of life’ as an outcome were extracted and inclusion criteria confirmed. Study and PRO characteristics were extracted. Completed trials that reported PRO outcomes and published manuscripts on ClinicalTrials.gov were identified, and PRO reporting details were extracted. Results 5.3% (548/10 372) DFOTs included PROs as an outcome. 231 (42.2%) were eligible: adult (224, 97%), solid tumour (175, 75.8%), and seamless phase 1/2 (108, 46.8%). PRO endpoints were identified in more trials (2.3 increase/year, 95% CI: 1.6–2.9) from an increasing variety of countries (0.7/year) (95% CI: 0.4–0.9) over time. PROs were typically secondary endpoints (207, 89.6%). 15/77 (19.5%) completed trials reported results on the ClinicalTrials.gov results database, and of those eight included their PRO results. Eighteen trials had published manuscripts available on ClinicalTrials.gov. Three (16.7%) used PROs to confirm the maximum tolerated dose. No trials identified who completed the PROs or how PROs were collected. Conclusions PRO use in DFOT has increased but remains limited. Future work should explore the role of PROs in DFOT and determine what guidelines are needed to standardise PRO use.
format	article
author	Julia Lai‐Kwon Zhulin Yin Anna Minchom Christina Yap
author_facet	Julia Lai‐Kwon Zhulin Yin Anna Minchom Christina Yap
author_sort	Julia Lai‐Kwon
title	Trends in patient‐reported outcome use in early phase dose‐finding oncology trials – an analysis of ClinicalTrials.gov
title_short	Trends in patient‐reported outcome use in early phase dose‐finding oncology trials – an analysis of ClinicalTrials.gov
title_full	Trends in patient‐reported outcome use in early phase dose‐finding oncology trials – an analysis of ClinicalTrials.gov
title_fullStr	Trends in patient‐reported outcome use in early phase dose‐finding oncology trials – an analysis of ClinicalTrials.gov
title_full_unstemmed	Trends in patient‐reported outcome use in early phase dose‐finding oncology trials – an analysis of ClinicalTrials.gov
title_sort	trends in patient‐reported outcome use in early phase dose‐finding oncology trials – an analysis of clinicaltrials.gov
publisher	Wiley
publishDate	2021
url	https://doaj.org/article/a51234f7e1fc4d6a9aa857b6e3ea186e
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Trends in patient‐reported outcome use in early phase dose‐finding oncology trials – an analysis of ClinicalTrials.gov

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