安晓玲 黄文强 苏雨楠 罗臻

中圖分类号 R969.4;R95 文献标志码 A 文章编号 1001-0408（2021）10-1153-05

DOI 10.6039/j.issn.1001-0408.2021.10.01

摘 要 目的：识别并评估创新药物临床试验的风险因素，为制定其风险管控策略提供参考。方法：运用文献研究法，获取创新药物临床试验阶段的风险因素，进行分类整理，初步形成风险评价指标，并在此基础上设计调查问卷;通过采用面谈访问、问卷调查等方式，邀请4家三甲医院及1家合同研究组织的54位专家进行评分;运用SPSS 24.0软件对风险事件状态数据进行主成分分析。结果与结论：形成的风险评估体系包括政策法律风险、临床试验机构风险、试验方案设计风险等9项一级指标，行业政策和法律法规变化、知识产权风险等31项二级指标。经分析，创新药物临床试验风险因素主要为药品及生物样本管理风险、试验方案设计风险、临床试验机构风险、安全性报告管理风险、伦理审查风险、政策法律风险和受试者管理风险等。临床试验相关方需要重点监测各风险因素，建立动态化的监控管控机制和实施保障机制，有效预防和管控风险，促进临床试验顺利实施。

关键词 创新药物临床试验;新政策环境;主成分分析法;风险识别;风险评估

Risk Identification and Evaluation of Clinical Trials of Innovative Drugs under New Policy Environment

AN Xiaoling，HUANG Wenqiang，SU Yunan，LUO Zhen（School of Pharmacy， Lanzhou University， Lanzhou 730030， China）

ABSTRACT   OBJECTIVE： To identify and evaluate the risk factors of innovative drug clinical trials， and to provide references for the development of risk management and control strategies. METHODS： Using the method of literature research， the risk factors of innovative drug clinical trials were obtained， classified and sorted out， and the risk evaluation indicators were initially formed. On this basis， the questionnaire was designed. By means of interview and questionnaire survey， 54 experts were invited from 4 tertiary hospitals and 1 contract research organization to score. SPSS 24.0 software was used to perform principal component analysis on risk event status data. RESULTS & CONCLUSIONS： The risk evaluation system included 9 first-class indicators such as policy and legal risk， clinical trial institution risk and trial scheme design risk， and 31 second-class indicators such as industrial policy， law and regulation changes， intellectual property risk. According to the analysis， the risk factors of innovative drug clinical trials mainly included drug and biological sample management risk， trial scheme design risk， clinical trial institution risk， safety report management risk， ethical review risk， policy and legal risk， and subject management risk. Relevant parties in clinical trials need to focus on monitoring various risk factors， establish dynamic monitoring and control mechanism and implementation guarantee mechanism， and effectively prevent and control risk， to promote the smooth implementation of clinical trials.

KEYWORDS   Clinical trials of innovative drugs; New policy environment; Principal component analysis; Risk identification; Risk evaluation

临床试验是评价创新药物有效性和安全性的关键环节，是创新药物能否上市的重要评判依据。由于临床试验耗时长、投资大、风险高，成为药物研发注册过程中的“限速步骤”，很大程度影响着创新药物的研发进程[1]。因此，在创新药物临床试验中引入风险管理非常必要。……