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dc.contributor.authorLai-Kwon, J
dc.contributor.authorVanderbeek, AM
dc.contributor.authorMinchom, A
dc.contributor.authorLee Aiyegbusi, O
dc.contributor.authorOgunleye, D
dc.contributor.authorStephens, R
dc.contributor.authorCalvert, M
dc.contributor.authorYap, C
dc.coverage.spatialEngland
dc.date.accessioned2022-09-13T08:50:23Z
dc.date.available2022-09-13T08:50:23Z
dc.date.issued2022-09-02
dc.identifier6618969
dc.identifier.citationThe Oncologist, 2022, 27 (9), pp. 768 - 777
dc.identifier.issn1083-7159
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/5442
dc.identifier.eissn1549-490X
dc.identifier.eissn1549-490X
dc.identifier.doi10.1093/oncolo/oyac117
dc.description.abstractBACKGROUND: Patient-reported adverse events may be a useful adjunct for assessing a drug's tolerability in dose-finding oncology trials (DFOT). We conducted surveys of international stakeholders and the National Cancer Research Institute (NCRI) Consumer Forum to understand attitudes about patient-reported outcome (PRO) use in DFOT. METHODS: A 35-question survey of clinicians, trial managers, statisticians, funders, and regulators of DFOT was distributed via professional bodies examining experience using PROs, benefits/barriers, and their potential role in defining tolerable doses. An 8-question survey of the NCRI Consumer Forum explored similar themes. RESULTS: International survey: 112 responses from 15 September-30 November 2020; 103 trialists [48 clinicians (42.9%), 38 statisticians (34.0%), 17 trial managers (15.2%)], 7 regulators (6.3%), 2 funders (1.8%)]. Most trialists had no experience designing (73, 70.9%), conducting (52, 50.5%), or reporting (88, 85.4%) PROs in DFOT. Most agreed that PROs could identify new toxicities (75, 67.0%) and provide data on the frequency (86, 76.8%) and duration (81, 72.3%) of toxicities. The top 3 barriers were lack of guidance regarding PRO selection (73/103, 70.9%), missing PRO data (71/103, 68.9%), and overburdening staff (68/103, 66.0%). NCRI survey: 57 responses on 21 March 2021. A total of 28 (49.1%) were willing to spend <15 min/day completing PROs. Most (55, 96.5%) preferred to complete PROs online. 61 (54.5%) trialists and 57 (100%) consumers agreed that patient-reported adverse events should be used to inform dose-escalation decisions. CONCLUSION: Stakeholders reported minimal experience using PROs in DFOT but broadly supported their use. Guidelines are needed to standardize PRO selection, analysis, and reporting in DFOT.
dc.formatPrint
dc.format.extent768 - 777
dc.languageeng
dc.language.isoeng
dc.publisherOXFORD UNIV PRESS
dc.relation.ispartofThe Oncologist
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectadverse events
dc.subjectcancer
dc.subjectclinical trials
dc.subjectdrug development
dc.subjectpatient-reported outcomes
dc.subjectquality of life
dc.titleUsing Patient-Reported Outcomes in Dose-Finding Oncology Trials: Surveys of Key Stakeholders and the National Cancer Research Institute Consumer Forum.
dc.typeJournal Article
dcterms.dateAccepted2022-04-26
dc.date.updated2022-09-13T08:48:55Z
rioxxterms.versionVoR
rioxxterms.versionofrecord10.1093/oncolo/oyac117
rioxxterms.licenseref.startdate2022-09-02
rioxxterms.typeJournal Article/Review
pubs.author-urlhttps://www.ncbi.nlm.nih.gov/pubmed/35762393
pubs.issue9
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Clinical Trials & Statistics Unit
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/The Adult Drug Development Unit at the ICR and the RM
pubs.publication-statusPublished
pubs.publisher-urlhttp://dx.doi.org/10.1093/oncolo/oyac117
pubs.volume27
icr.researchteamAdult DDU ICR & RM
icr.researchteamClin Trials & Stats Unit
dc.contributor.icrauthorMinchom, Anna
dc.contributor.icrauthorYap, Christina
icr.provenanceDeposited by Mr Arek Surman on 2022-09-13. Deposit type is initial. No. of files: 1. Files: Using Patient-Reported Outcomes in Dose-Finding Oncology Trials Surveys of Key Stakeholders and the National Cancer Research.pdf


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