特殊药品临床试验的全流程闭环药物管理模式探索OA

The clinical trial management of special drugs must comply with both the specialized regulatory requirements for special drugs and Good Clinical Practice(GCP).With the annual increase in the number of clinical trials involving special drugs in China,the traditional centralized management model has become inadequate to meet their complex regulatory demands.This paper focuses on drug management in clinical trials of special drugs and conducts research based on practical experience from our institution.It methodically contrasts the management differences between special drugs and regular trial drugs,pinpointing the core challenges in the industry.These issues include inconsistent implementation standards,limited full-process traceability capacities,and heightened risk management difficulties.Consequently,a closed-loop management framework is put forward,which is marked by centralized management as the core and departmental collaborative management as the supplement.The crucial aspects of implementation within this framework are further elucidated across three management spheres:personnel,data,and risk prevention.The objective is to improve management effectiveness and quality,reinforce risk management,present a replicable practical paradigm for domestic medical institutions carrying out clinical trials of special drugs,and provide empirical references for regulatory authorities to refine relevant standards.