我国药物临床试验为受试者提供保险的调查与分析

Investigation and analysis of insurance for volunteers in clinical trials of drugs in China

目的:分析我国临床试验保险的实施现状及存在的问题,为我国临床试验保险发展提出建议。方法:统计登记在国家食品药品监督管理局药品审评中心的5973条临床试验数据。结果:我国临床试验保险覆盖率随逐年增长但总体仍较低;外资企业购买保险意识明显高于国内企业;高风险试验保险覆盖率较高,中药及天然产物试验保险覆盖率极低;上海、北京等地对受试者的保护意识强等。结论:医药行业应加强保险意识,对受试者提供全面保障;企业应加强风险管理意识,落实国家政策,推动医药行业健康发展。

Objective: Analyze the implementation status and existing problems of clinical trial insurance in China, and provide suggestions for the development of clinical trial insurance in China. Methods: The 5973 clinical trial data registered in CDE( Center for Drug Evaluation, CFDA) were analyzed. Results : Clinical trial insurance coverage of China has increased year by year but overall is still low. Foreign-invested enterprises have a higher awareness of purchasing insurance than domestic enterprises. Chinese medicine and natural products clinical trial insurance coverage is extremely low. Shanghai, Beijing and other places have strong awareness of the protection of subjects, etc. Conclusion: The pharmaceutical industry should strengthen insurance awareness and provide comprehensive protection for the subjects. Enterprises should strengthen their awareness of risk management,implement national policies, and promote the healthy development of the pharmaceutical industry.