| 樊红延,胡敬峰,赵婷婷,张建永,冯巧巧.基于疗效指标的药物临床试验现场核查关注点分析[J].中国药事,2023,(8):864-869 |
| 基于疗效指标的药物临床试验现场核查关注点分析 |
| Analysis on Concerns of Efficacy Indicators in Drug Clinical Trial On-site Inspection |
| 投稿时间：2022-09-28 |
| DOI：10.16153/j.1002-7777.2023.08.002 |
| 中文关键词: 药物临床试验 疗效指标 现场核查 疗效评估 |
| 英文关键词: drug clinical trials effi cacy indicators on-site inspection effi cacy evaluation |
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| 中文摘要: |
| 目的：分析药物临床试验现场核查过程中疗效指标相关问题的关注点，为药物临床试验现场核查工作提供参考。方法：参考国内外药物临床试验实施和检查相关指导性文件，对疗效指标相关核查要点进行总结；并结合近年来现场核查经典案例，梳理核查过程中不同试验设计的药物临床试验常用的疗效评价指标及对应的常见问题，分析现场核查的关注点。结果：通过案例分析，明确了疾病临床终点或相关重要临床事件类疗效指标、量表类疗效指标、实验室检测结果类疗效指标、影像学结果类疗效指标4 类常用疗效评价指标的现场核查关注点。结论：不同类型的疗效指标具有不同的评估要求、评估标准和评估流程，现场核查过程中应有针对性地考虑适当的关注点，才能使核查工作更加高质高效地开展。 |
| 英文摘要: |
| Objective: To analyze the focus points of efficacy indicators related issues during the on-site inspections of drug clinical trials, and provide references for such relevant inspections. Methods: On the basis of domestic and international guidance documents related to the implementation and inspections of drug clinical trials, this article summarizes the key points of inspections related to efficacy indicators. Combined with the classical cases of on-site inspections in recent years, the effi cacy evaluation indexes and corresponding problems in drug clinical trials with diff erent trial designs are sorted out and the focus of on-site inspections are analyzed. Results: Through the case analysis, this article further clarifi ed the focus of on-site inspections related to four common types of evaluation indexes, including clinical endpoint of disease or related important clinical events effi cacy indicators, scale effi cacy indicators, laboratory test results effi cacy indicators, and imaging results effi cacy indicators. Conclusion: Diff erent types of effi cacy indicators have diff erent evaluation requirements, standards and processes. In the process of on-site inspections, the specifi c focus should be taken into account properly in order to make the work more high-quality and effi cient. |
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