dc.contributor.author | Villacampa, G | |
dc.contributor.author | Patel, D | |
dc.contributor.author | Zheng, H | |
dc.contributor.author | McAleese, J | |
dc.contributor.author | Rekowski, J | |
dc.contributor.author | Solovyeva, O | |
dc.contributor.author | Yin, Z | |
dc.contributor.author | Yap, C | |
dc.date.accessioned | 2023-06-30T14:16:50Z | |
dc.date.available | 2023-06-30T14:16:50Z | |
dc.date.issued | 2023-06-01 | |
dc.identifier | 102020 | |
dc.identifier.citation | EClinicalMedicine, 2023, 60 pp. 102020 - 102020 | |
dc.identifier.issn | 2589-5370 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/5862 | |
dc.identifier.doi | 10.1016/j.eclinm.2023.102020 | |
dc.description.abstract | BACKGROUND: The paradigm of early phase dose-finding trials has evolved in recent years. Innovative dose-finding designs and protocols which combine phases I and II are becoming more popular in health research. However, the quality of these trial protocols is unknown due to a lack of specific reporting guidelines. Here, we evaluated the reporting quality of dose-finding trial protocols. METHODS: We conducted a cross-sectional study of oncology and non-oncology early phase dose-finding trial protocols posted on ClinicalTrials.gov in 2017-2023. A checklist of items comprising: 1) the original 33-items from the SPIRIT 2013 Statement and 2) additional items unique to dose-finding trials were used to assess reporting quality. The primary endpoint was the overall proportion of adequately reported items. This study was registered with PROSPERO (no: CRD42022314572). FINDING: A total of 106 trial protocols were included in the study with the rule-based 3 + 3 being the most used trial design (39.6%). Eleven model-based and model-assisted designs were identified in oncology trials only (11/58, 19.0%). The overall proportion of adequately reported items was 65.1% (95%CI: 63.9-66.3%). However, the reporting quality of each individual item varied substantially (range 9.4%-100%). Oncology study protocols showed lower reporting quality than non-oncology. In the multivariable analysis, trials with larger sample sizes and industry funding were associated with higher proportions of adequately reported items (all p-values <0.05). INTERPRETATION: The overall reporting quality of early phase dose-finding trial protocols is suboptimal (65.1%). There is a need for improved completeness and transparency in early phase dose-finding trial protocols to facilitate rigorous trial conduct, reproducibility and external review. FUNDING: None. | |
dc.format.extent | 102020 - 102020 | |
dc.language | en | |
dc.language.iso | eng | |
dc.publisher | ELSEVIER | |
dc.relation.ispartof | EClinicalMedicine | |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | |
dc.title | Assessing the reporting quality of early phase dose-finding trial protocols: a methodological review. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2023-05-25 | |
dc.date.updated | 2023-06-27T08:50:43Z | |
rioxxterms.version | VoR | |
rioxxterms.versionofrecord | 10.1016/j.eclinm.2023.102020 | |
rioxxterms.licenseref.startdate | 2023-06-01 | |
rioxxterms.type | Journal Article/Review | |
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.publication-status | Published | |
pubs.publisher-url | http://dx.doi.org/10.1016/j.eclinm.2023.102020 | |
pubs.volume | 60 | |
icr.researchteam | Clin Trials & Stats Unit | |
dc.contributor.icrauthor | Yap, Christina | |
icr.provenance | Deposited by Mrs Jessica Perry (impersonating Prof Christina Yap) on 2023-06-27. Deposit type is initial. No. of files: 1. Files: Assessing the reporting quality of early phase dosefinding trial protocols, a methodological review.pdf | |