Assessing the reporting quality of early phase dose-finding trial protocols: a methodological review.
Assessing the reporting quality of early phase dose-finding trial protocols: a methodological review.
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DOI：
10.1016/j.eclinm.2023.102020
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发表时间：
2023-06
影响因子：
15.1
通讯作者：
Yap, Christina
中科院分区：
文献类型：
--
作者：
Villacampa, Guillermo;Patel, Dhrusti;Zheng, Haiyan;McAleese, Jessica;Rekowski, Jan;Solovyeva, Olga;Yin, Zhulin;Yap, Christina
近年来，早期剂量发现试验的模式有所发展。结合第一阶段和第二阶段的创新剂量测定设计和方案在卫生研究中越来越受欢迎。然而，由于缺乏具体的报告指南，这些试验方案的质量尚不清楚。在这里，我们评估了剂量寻找试验方案的报告质量。我们对2017-2023年发布在ClinicalTrials.gov上的肿瘤和非肿瘤早期剂量发现试验方案进行了横断面研究。项目清单包括：1)SPIRIT 2013年声明中最初的33个项目和2)剂量发现试验特有的附加项目，用于评估报告质量。主要终点是充分报告项目的总体比例。本研究已在PROSPERO注册（编号：CRD42022314572）。本研究共纳入106个试验方案，其中基于规则的3 + 3是使用最多的试验设计（39.6%）。仅在肿瘤学试验中发现了11种基于模型和模型辅助的设计（11/58,19.0%）。充分报告项目的总体比例为65.1% （95%CI: 63.9-66.3%）。然而，每个单独项目的报告质量差异很大（范围为9.4%-100%）。肿瘤研究方案的报告质量低于非肿瘤研究方案。在多变量分析中，样本量较大和行业资助的试验与充分报告项目的比例较高相关（所有p值<0.05）。早期剂量发现试验方案的总体报告质量是次优的（65.1%）。需要提高早期剂量测定试验方案的完整性和透明度，以促进严格的试验进行、可重复性和外部审查。没有。
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. 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). 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). 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. None.
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DOI：
10.1200/edbk_319783
发表时间：
2021-06-01
期刊：
American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting
影响因子：
--
作者：
Kurzrock, Razelle;Lin, Chia-Chi;Hong, David S
通讯作者：
Hong, David S
影响因子：
8.8
作者：
Love SB;Brown S;Weir CJ;Harbron C;Yap C;Gaschler-Markefski B;Matcham J;Caffrey L;McKevitt C;Clive S;Craddock C;Spicer J;Cornelius V
通讯作者：
Cornelius V
影响因子：
2.9
作者：
Tan, Zet Wei;Tan, Aidan Christopher;Adie, Sam
通讯作者：
Adie, Sam
影响因子：
2.9
作者：
通讯作者：
--
DOI：
10.1136/bmj.e7586
发表时间：
2013-01-08
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Chan AW;Tetzlaff JM;Gøtzsche PC;Altman DG;Mann H;Berlin JA;Dickersin K;Hróbjartsson A;Schulz KF;Parulekar WR;Krleza-Jeric K;Laupacis A;Moher D
通讯作者：
Moher D