从合同研究组织角度出发谈药物临床试验伦理审评效率

Efficiency of ethical review of drug clinical trials from contract research organization perspective

目的讨论制约国内药物临床试验伦理审评时效的主要因素,提出我国药物临床试验伦理审评效率的改进建议。方法整理某单位过去3年内承接项目的伦理审评时限,以不同洲际、不同国家、国内不同地区为分类标准,多维度比较分析国内外药物临床试验伦理审评时效差异。结果典型国家平均伦理审评时限:中国(49 d)>英国(23 d)>日本(18 d)>美国(9 d)。结论我国药物临床试验伦理审评效率相较其他国家整体较低,且各地区差异明显,希望从国家政策、企业模式和研究中心流程等方面进行优化改善。

Objective To discuss the main factors restricting the prescription of ethical review of drug clinical trials in China and to put forward suggestions on improving the efficiency.Methods The cycle time of ethical review of the projects undertaken by the internship unit in past 3 years was summarized.The difference in the cycle time of ethical review between China and abroad was compared and analyzed by using different countries and different regions in China as classification standards.Results The average cycle time of ethical review in typical countries is as follows:China 49 days>United Kingdom 23 days>Japan 18 days>United States 9 days.Conclusion The efficiency of ethical review of drug clinical trials in China is lower than that in other countries,and there are also significant regional differences in China.It is hoped to optimize and improve the efficiency from the aspects of national policy,enterprise model and clinical research sites.