军队新药研发项目的风险评估体系研究  

Risk evaluation system of new drug research and development projects in the military

作　　者：陈静[1] 陆峰[1] 舒丽芯[1] 

机构地区：[1]第二军医大学药学系,上海200433

出　　处：《药学实践杂志》2017年第1期54-59,共6页Journal of Pharmaceutical Practice

摘　　要：目的风险管理是保证新药研发项目顺利进行的强有力措施。因此,建立适合新药研发项目的风险评估指标体系对提高医药项目成功率至关重要。方法对近5年来"军队科技重大专项"支持的20多个新药研发项目进行分析,归纳、整理和总结出新药研发项目的风险因素,通过德尔菲法和专家访谈法明确风险评价指标体系,并采用基于层次分析法的模糊综合评价法,对体系的指标进行定量研究。结果按照不同阶段的新药研发项目,分别建立了药物候选阶段、药物临床前阶段和药物临床阶段的风险评估指标体系和权重。结论本指标体系较为客观准确,有助于新药研发项目中的风险控制。Objective Risk management is one of the strong measurements to ensure the conduction of new drug research and development （R＆D） projects. Therefore, establishing a set of evaluation index system in the new drug R＆D projeets is of great significance to increase the project success rate. Methods By analyzing more than 20 new drug R＆D projects of ＂the military science and technology major projects＂ in five years, the risk factors were induced, sorted and summed up, and a set of evaluation indicator was built up through Delphi method and experts interview. The quantitative study was completed through fuzzy comprehensive evaluation method. Results According to the different stages of new drug R＆D projects, the risk assessment indictors and their weight were established. Conclusion These indicators are more objective and accurate which contribute to the risk control in the process of new drug R＆D projects.

关 键 词：药品研发项目 风险管理 评价指标 模糊综合评价法 

分 类 号：R954[医药卫生—药学]