dc.contributor.author | Lai-Kwon, J | |
dc.contributor.author | Vanderbeek, AM | |
dc.contributor.author | Minchom, A | |
dc.contributor.author | Lee Aiyegbusi, O | |
dc.contributor.author | Ogunleye, D | |
dc.contributor.author | Stephens, R | |
dc.contributor.author | Calvert, M | |
dc.contributor.author | Yap, C | |
dc.coverage.spatial | England | |
dc.date.accessioned | 2022-09-13T08:50:23Z | |
dc.date.available | 2022-09-13T08:50:23Z | |
dc.date.issued | 2022-09-02 | |
dc.identifier | 6618969 | |
dc.identifier.citation | The Oncologist, 2022, 27 (9), pp. 768 - 777 | |
dc.identifier.issn | 1083-7159 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/5442 | |
dc.identifier.eissn | 1549-490X | |
dc.identifier.eissn | 1549-490X | |
dc.identifier.doi | 10.1093/oncolo/oyac117 | |
dc.description.abstract | BACKGROUND: 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.format | Print | |
dc.format.extent | 768 - 777 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | OXFORD UNIV PRESS | |
dc.relation.ispartof | The Oncologist | |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | |
dc.subject | adverse events | |
dc.subject | cancer | |
dc.subject | clinical trials | |
dc.subject | drug development | |
dc.subject | patient-reported outcomes | |
dc.subject | quality of life | |
dc.title | Using Patient-Reported Outcomes in Dose-Finding Oncology Trials: Surveys of Key Stakeholders and the National Cancer Research Institute Consumer Forum. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2022-04-26 | |
dc.date.updated | 2022-09-13T08:48:55Z | |
rioxxterms.version | VoR | |
rioxxterms.versionofrecord | 10.1093/oncolo/oyac117 | |
rioxxterms.licenseref.startdate | 2022-09-02 | |
rioxxterms.type | Journal Article/Review | |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/35762393 | |
pubs.issue | 9 | |
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-status | Published | |
pubs.publisher-url | http://dx.doi.org/10.1093/oncolo/oyac117 | |
pubs.volume | 27 | |
icr.researchteam | Adult DDU ICR & RM | |
icr.researchteam | Clin Trials & Stats Unit | |
dc.contributor.icrauthor | Minchom, Anna | |
dc.contributor.icrauthor | Yap, Christina | |
icr.provenance | Deposited 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 | |