基于风险的Ⅰ期临床试验质量管理探讨

Discussion on quality management of phase Ⅰ clinical trials based on risk

药物临床试验的质量是保护受试者权益和科学评价药物的重要前提。Ⅰ期临床试验是初步的临床药理学及人体安全性评价试验,较Ⅱ/Ⅲ期临床试验全程高风险,如何实现效益-风险最优化一直是被关注的核心问题。针对Ⅰ期临床试验和Ⅰ期临床试验室管理的特点,通过对系统层面和项目层面的风险因素进行识别、评估,提出基于风险的质量管理策略,采取有效措施,全面和持续性降低整个Ⅰ期临床试验周期的风险。

The quality of drug clinical trials is an important prerequisite for protecting the rights of subjects and evaluating drugs scientifically. As a preliminary clinical pharmacology and human safety evaluation trial,the risk of Phase Ⅰ clinical trial’s process is high compared with the Ⅱ/Ⅲ phase clinical trials. Therefore,it always has been the core concern of how to achieve the benefit risk optimization. According to the characteristics of PhaseⅠ clinical trial and Phase Ⅰ clinical laboratory management,the risk factors at system level and project level were identified and evaluated,and the risk-based quality management strategy was proposed. Effective measures should be taken to reduce the risk of Phase Ⅰ clinical trial cycle comprehensively and continuously.