Assessing the reporting quality of early phase dose-finding trial protocols: a methodological review.
Date
2023-06-01ICR Author
Author
Villacampa, G
Patel, D
Zheng, H
McAleese, J
Rekowski, J
Solovyeva, O
Yin, Z
Yap, C
Type
Journal Article
Metadata
Show full item recordAbstract
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.
Collections
Research team
Clin Trials & Stats Unit
Language
eng
Date accepted
2023-05-25
License start date
2023-06-01
Citation
EClinicalMedicine, 2023, 60 pp. 102020 - 102020
Publisher
ELSEVIER