中药新药临床试验报告安全性分析方面的常见问题

Common issues in safety analysis of clinical trail reports for new drugs of traditional Chinese medicine

临床试验报告是对药物临床试验过程和结果的总结,是支持药物上市有效性和安全性评价的重要依据以及药品注册所需的重要技术资料。安全性分析是临床试验报告中的主要部分,也是出现问题频率最高的部分。该文结合中药创新药上市许可申请的临床专业审评情况,总结和分析审评中发现的中药新药临床试验报告安全性分析部分的常见问题,主要针对报告不完整和分析不充分2个方面,包括漏报不良事件和实验室检查结果、未提供详细的实验室检查异常值列表、不良事件与药物因果关系分析缺乏专业深度等。针对存在的共性和常见问题,提出从用药程度、不良反应/事件、实验室检查3个维度进行必要的医学分析、整理与总结临床试验报告安全性分析质量方面的建议。

Clinical trail report is a summary of the process and results of clinical trail,an important basis to support the effectiveness and safety evaluation of drug marketing and an important technical data required for drug registration.Safety analysis is the main part and the most common issue of clinical trial report.In this article,it is summarized and analyzed the common problems found in the safety analysis part of the clinical trial report of new drugs of traditional Chinese medicine(TCM)in combination with the clinical professional evaluation of the application for marketing license of innovative TCM.The common problems in writing the safety aspects of clinical trail reports were summarized and analyzed,including the omissions of adverse events and laboratory test results,the failure to provide a detailed list of laboratory test outliers,the lack of professional depth in the analysis of the causal relationship between adverse events and TCM.In view of the common problems,it is suggested that the drug use degree,adverse events and adverse reactions,as well as laboratory examination should be considered.Check the three dimensions for necessary medical analysis,collation and summary and continuously improve the quality of safety analysis in clinical trial reports.