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Assessing the reporting quality of early phase dose-finding trial protocols: a methodological review.
Villacampa, Guillermo; Patel, Dhrusti; Zheng, Haiyan; McAleese, Jessica; Rekowski, Jan; Solovyeva, Olga; Yin, Zhulin; Yap, Christina.
Afiliación
  • Villacampa G; Clinical Trials and Statistics Unit at The Institute of Cancer Research (ICR-CTSU), United Kingdom.
  • Patel D; Clinical Trials and Statistics Unit at The Institute of Cancer Research (ICR-CTSU), United Kingdom.
  • Zheng H; MRC Biostatistics Unit, University of Cambridge, United Kingdom.
  • McAleese J; Clinical Trials and Statistics Unit at The Institute of Cancer Research (ICR-CTSU), United Kingdom.
  • Rekowski J; Clinical Trials and Statistics Unit at The Institute of Cancer Research (ICR-CTSU), United Kingdom.
  • Solovyeva O; Clinical Trials and Statistics Unit at The Institute of Cancer Research (ICR-CTSU), United Kingdom.
  • Yin Z; Clinical Trials and Statistics Unit at The Institute of Cancer Research (ICR-CTSU), United Kingdom.
  • Yap C; Clinical Trials and Statistics Unit at The Institute of Cancer Research (ICR-CTSU), United Kingdom.
EClinicalMedicine ; 60: 102020, 2023 Jun.
Article en En | MEDLINE | ID: mdl-37261325
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.
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Texto completo: 1 Bases de datos: MEDLINE Tipo de estudio: Diagnostic_studies / Guideline / Observational_studies / Prognostic_studies / Risk_factors_studies Idioma: En Revista: EClinicalMedicine Año: 2023 Tipo del documento: Article País de afiliación: Reino Unido

Texto completo: 1 Bases de datos: MEDLINE Tipo de estudio: Diagnostic_studies / Guideline / Observational_studies / Prognostic_studies / Risk_factors_studies Idioma: En Revista: EClinicalMedicine Año: 2023 Tipo del documento: Article País de afiliación: Reino Unido