从目前我国临床科研工作开展的现状浅议如何开展负责任的临床研究

How to carry out responsible clinical research from the current situation of clinical research in China

通过梳理和分析以《关于加强科技伦理治理的意见》为核心的一系列文件出台的政策背景,深入分析当今我国临床研究工作开展的现状和存在的问题。在此基础上,提出在未来规范开展临床研究所面临的实际困难及初步的解决方案。“科技向善,伦理先行”的核心要义要求开展负责任的临床研究,如何负责任地开展临床研究和如何践行“以患者为中心”的临床研究是此问题的两个方面。进一步健全完善涉及人的生命科学和医学研究伦理审查监督管理体系建设,有效防控科技伦理风险,推动生命科学和医学研究更多、更好地造福人民群众健康,是主动防范化解风险、提高国家治理体系和治理能力现代化水平、提升国家创新体系整体效能的要求。

By combing and analyzing the policy background of a series of documents with the core of Opinions on Strengthening the Ethical Governance of Science and Technology,this paper deeply analyzes the present situation and existing problems of clinical research in China.On this basis,the practical difficulties and preliminary solutions to standardize clinical research in the future are put forward.The core essence of“technology for social good,and ethics upfront”requires responsible clinical research.How to carry out clinical research responsibly and how to practice“patient-centered”clinical research are two aspects of this problem.Further improving and perfecting the construction of ethical review supervision and management system of life sciences and medical research involving people,effectively preventing and controlling ethical risks of science and technology,and promoting life sciences and medical research to benefit people's health more and better are the requirements for actively preventing and resolving risks,improving the modernization level of national governance system and governance capacity,and enhancing the overall efficiency of national innovation system.