降糖药临床试验不依从/违背方案事件的特点与管理策略

Characteristics and Management Strategies of Non-compliance/Violation Protocol in Clinical Trials of Hypoglycemic Drugs

目的分析降糖药临床试验中违背方案事件的特点,探讨违背方案事件的管理策略。方法采用根原因分析法,对某医院内分泌科近几年承接的降糖药临床试验进行回顾性分析,统计试验实施过程中违背方案事件的类别、发生率和影响因素。结果降糖药临床试验发生的265例次违背方案事件,93.58%为轻度违背,重度违背仅占6.42%。所有违背中,以未按照中心实验室的要求管理生物样本、未执行已批准的研究程序和未按照试验方案用药发生率最高。结论申办者和研究团队可引入基于风险的质量管理体系,通过早期识别、定期监测和评估关键风险并制定防控措施加强降糖药临床试验的质量管理,减少临床试验不依从/违背方案事件的发生。

Objective To analyze the characteristics of events violating the protocol in clinical trials of hypoglycemic drugs,and to explore the management strategies of events violating the protocol.Methods The clinical trials of hypoglycemic drugs undertaken by endocrinology department of a hospital in recent years were retrospectively analyzed by root cause analysis,and the categories,incidence and influencing factors of events violating the protocol during the implementation of the trials were counted.Results Of the 265 cases of violating the protocol in clinical trials of hypoglycemic drugs,93.58%were mild violations,and only 6.42%were severe violations.Among all violations,the events of highest incidence rate included that the biological samples were not managed according to the requirements of the central laboratory,the approved research procedures were not implemented,and the drugs were not used according to the test plan.Conclusion The sponsor and the research team can introduce a risk-based quality management system to strengthen the quality management of clinical trials of hypoglycemic drugs by early identification,regular monitoring and evaluation of key risks and formulating prevention and control measures,so as to reduce the occurrence of non-compliance and violation of clinical trials.