精确科学沟通的重要性:非随机试验不应被描述为第三阶段,注册意图试验不应被描述为第二阶段
Brant A Inman1, Andrew J Vickers2
1Division of Urology, Department of Oncology, Western University, London, Canada.
European urology
|March 21, 2025
概括
标准化临床试验命名对于准确反映研究设计至关重要. 这样可以确保第一阶段 (首次在人体内发现剂量),第二阶段 (安全性和有效性) 和第三阶段 (标准护理比较) 的术语与试验目标准确匹配.
科学领域:
- 临床研究方法论临床研究方法论
- 药物开发过程 药物开发过程
- 生物医学研究设计
背景情况:
- 当前的临床试验术语缺乏标准化,导致研究设计定义的模两可.
- 第1期,第2期和第3期试验描述往往与其实际执行不一致.
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