摘要
目的:探讨基于风险监查方法在研究者发起的临床研究中应用的科学性和可行性。方法:对国家药品监督管理局(NMPA)颁布的《药物临床试验质量管理规范》,美国FDA颁布的《基于风险的临床试验监查方法指导原则》和《基于风险的临床试验监查方法-问题与解答指南草案》等文件进行分析,结合研究者发起的临床研究实践经验,总结基于风险监查的流程与实施建议。结果:建议研究者发起的临床研究采用基于风险的监查策略,实施步骤一般为确定研究关键流程和关键数据,对项目进行风险评级,制定监查计划时根据风险级别采用相应的监查方式和方法,同时还应在临床研究开展过程中,对研究中心风险及数据质量定期评估,掌握不同中心风险变化趋势,适时调整监查的方式、内容和频率。结论:在研究者发起的临床研究中使用基于风险的监查策略具有科学性和可行性,基于风险的监查可满足临床试验对数据质量的要求,不影响主要结局的分析结果,同时可进一步提高监查效率和效果。
Objective To discuss the scientificity and feasibility of risk-based monitoring strategies in Investigator initiated Trials.Methods"Guideline for Good Clinical Practice"promulgated by NMPA,"Oversight of Clinical Investigations-a Risk-based Approach to Monitoring"and"A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry DRAFT GUIDANCE"promulgated by the US FDA and other documents were analyzed,the practical experience of Investigator initiated Trials was also summarized.Results It was recommended that clinical investigators use risk-based monitoring strategies in Investigator initiated Trials.The main idea of risk-based monitoring is to determine the key process and key data of the study,carry out risk rating on the project,and adopt corresponding monitoring methods according to the risk level when formulating the monitoring plan.At the same time,during the clinical trial development process,the risk and data quality of the research center should be regularly evaluated to grasp the risk changes of different centers.In accordance with trends,adjust the method,content and frequency of monitoring.Conclusions To apply risk-based monitoring strategies in Investigator initiated Trials is scientificity and feasibility.Risk based monitoring can meet the data quality requirements of clinical trials,without affecting the analysis results of the main outcomes,and can further improve the efficiency and effectiveness of monitoring.
作者
袁宝石
王胤凯
倪如月
吕微
孟霞
Yuan Baoshi;Wang Yinkai;Ni Ruyue;Lv Wei;Meng Xia(Beijing Tiantan Hospital,Capital Medical University,Beijing 100070,China;China National Clinical Research Center for Neurological Diseases,Beijing 100070,China)
出处
《中华医学科研管理杂志》
2023年第3期182-188,共7页
Chinese Journal of Medical Science Research Management