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临床研究资源作为各国参与生物医药高技术领域国际竞争的重要资源,在开展多中心临床研究,将基础研究成果转化为临床实践的过程中发挥着重要作用。中国人口众多、疾病种类丰富,但临床疾病研究的相关政策法规不够完善。相比之下,美国临床研究资源的发展较为规范,并建立了系统的相关政策加以指导。该文通过对中美两国的疾病资源、平台支持、监管环境等进行对比分析,提出利用临床研究资源的几点建议,为我国的临床研究提供参考借鉴。
As an important resource for all countries to participate in the international competition in biomedical high-tech fields, clinical research resources play an important role in carrying out multicenter clinical research and transforming basic research results into clinical practice. China has a large population and various types of diseases, but the relevant policies and regulations on clinical disease research are not perfect. In contrast, the development of clinical research resources in the United States is more standardized and a system-related policy has been established to guide it. By comparing and analyzing the disease resources, platform support and regulatory environment in China and the United States, this paper puts forward some suggestions on using clinical research resources to provide reference for clinical research in China.