临床试验期间可疑且非预期严重不良反应报告的管理探讨

Discussion on the management of Suspected Unexpected Serious Adverse Reaction reports during clinical trials

目的根据国家药品监督管理局新颁布的GCP法规, 探讨临床试验期间可疑且非预期严重不良反应报告的管理模式。方法通过GCP法规结合实际工作情况, 综合分析试验期间可疑且非预期严重不良反应报告的管理问题及其原因并提出相应对策。结果试验各方对可疑且非预期严重不良反应报告的管理存在相应义务和职责履行瑕疵等问题, 研究者认真履行GCP职责、申办者准确执行报告程序、机构和伦理加强监管力度有利于临床试验更好地开展。结论多方配合的管理模式才能完成高质量的临床试验。

Objective According to the new GCP regulations issued by national medical products administration,this paper discusses the management mode of Suspected Unexpected Serious Adverse Reaction(SUSAR)reports during clinical trials.Methods Combined with GCP regulations and working practice,this paper comprehensively analyzes the issues identified and related reasons for the management of SUSAR reports during clinical trials,and propose possible countermeasures.Results There are some problems in the management of SUSAR reports among different stakeholders during clinical trials,such as defects in the performance of obligations and responsibilities.It is suggested that investigators should be more carefully to fulfill GCP responsibilities;sponsors should be more accurately implement the reporting procedures;institutional and ethical supervision should also be strengthened to assure better conduct of clinical trials.Conclusions Multi-party collaboration and management mode play crucial roles in conducting high-quality clinical trials.