药物临床试验监管新政要点解析

目的分析我国出台的药物临床试验相关政策法规及其对我国临床研究工作的影响。方法通过梳理《药物临床试验质量管理规范》相关法律法规及新政的修订理念、修订要点,查阅文献,分析我国现阶段药物临床试验发展面临的机遇与挑战,并提出对策及建议。结果与结论借鉴国际先进经验、细化相关法规、加强与申办者的沟通交流、加大对申办者和合同研究组织的监管、引导申办者选择合适的试验机构、加强专业人才储备,可推动解决我国药物临床试验监管过程中存在的问题和不足,对于提高我国药物临床试验从业者积极性,促进我国药物自主研发有重大意义。

Key Points Analysis of the New Regulatory Policy of Drug Clinical Trials

Objective To analyze the policies and regulations related to drug clinical trials and their impact on clinical research in China.Methods The opportunities and challenges in the development of drug clinical trials in China at the present were analyzed by sorting out the relevant laws and regulations of the Good Clinical Practice(GCP)and the revision ideas and key points of the new policy,and conducting the relevant literature,the countermeasures and suggestions were put forward.Results and Conclusion Learning from the advanced international experience,refining the relevant laws and regulations,strengthening the communication with the applicants,increasing the supervision of the applicants and contract research organizations,guiding the applicants to choose the appropriate test institutions,and strengthening the reserve of professional talents can promote the solution of the problems and deficiencies existing in the supervision process of drug clinical trials in China,it is of great significance to improve the enthusiasm of clinical trial practitioners and promote the independent research and development of drugs in China.