新药研发中药物临床试验方案的风险管理

本文为新药临床试验风险管理提供参考。在临床试验方案中引入风险管理方法，从风险管理的基本程序：风险识别、风险评估、风险控制等方面展开论证。充分认识和把握临床试验方案中存在的风险因素：临床前研究资料不足的风险、入选与排除标准制订的风险、有效性与安全性评价的风险、统计设计的风险、研究者和受试者依从性的风险等。根据风险性质的不同，可采用风险减轻、风险规避、风险转移、风险接受等控制措施，以有效减少后期临床试验过程中风险发生和降低损失。

Risk management of drug clinical trials program in the drug research and development

Objective: To provide a reference for risk management of clinical trials. Methods: Risk management approaches were introduced in the design of clinical trial protocols, including the identification, assessment and intervention of risks. Results and Conclusion: Clinical trial protocol risks are mainly: lack of pre-clinical research materials, inclusion and exclusion criteria formulation, efficacy and safety evaluation, statistical design, the compliance of investigators and subjects. Depending on the nature of the risks, using risk reduction, risk avoidance, risk transfer, risk acceptance, the risks and losses of clinical trials can be effectively reduced in late-stage.