药物临床试验SAE报告存在问题及对策

发布时间：2018-08-27 14:45

【摘要】：目的:通过分析总结药物临床试验过程中SAE上报出现的问题,提出规范的报告方法,为提高药物临床试验质量提供参考。方法:采用回顾性总结分析的方法,对某院某专业组2010-2016年进行的10项药物临床试验发生的共计69例SAE报告进行归类分析,总结存在的问题,探讨符合GCP规范的报告方法和相关建议。结果:分析的SAE报告中,出现的主要问题依次有:研究者获知SAE后未在规定时限内上报(占1.4%);SAE报告表填写不规范(占66.7%);原始记录不完整(占2.9%);SAE报告回执收集不全(占2.9%);特殊情况未备注(占1.4%)。产生上述问题的主要原因有研究者GCP及方案培训不达标、对严重不良事件的理解与重视程度参差不齐、对SAE上报环节不够清楚,给SAE的管理与上报带来一定难度。结论:加强对研究者的培训,建立SAE上报的SOP,制定相应的SAE填报指引,加强对患者的宣教是提高药物临床试验SAE上报质量的办法。
[Abstract]:Objective: to provide a reference for improving the quality of drug clinical trials by analyzing and summarizing the problems of SAE reporting in clinical trials. Methods: a total of 69 cases of SAE reports of 10 drug clinical trials conducted in a hospital from 2010 to 2016 were classified and analyzed by the method of retrospective summary and analysis, and the existing problems were summarized. To discuss the reporting methods and related recommendations in accordance with GCP specifications. Results: in the analysis of the SAE report, The main problems were as follows: the SAE was not reported within the prescribed time limit (1.4%), the original record was incomplete (2.9%), the collection of receipt was not complete (2.9%), and the special case was not noted (1.4%). The main reasons for the above problems are that the GCP and the scheme training are not up to standard, the degree of understanding and attention to the serious adverse events is not uniform, and the reporting link of SAE is not clear enough, which brings some difficulties to the management and reporting of SAE. Conclusion: strengthening the training of the researchers, establishing the SOP, reported by SAE and establishing the corresponding SAE reporting guidelines, and strengthening the propaganda and education to the patients are the ways to improve the quality of the SAE reporting in the drug clinical trials.
【作者单位】：广东省医学科学院广东省人民医院风湿科;
【分类号】：R95

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