中国与美国临床研究资源的对比分析

Comparative analysis of clinical research resources between China and the United States

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 a country to participate in international high-tech competition in the bio-pharmaceutical field,clinical research resources play a key role in the multi-center clinical research and the translation from basic research to clinical practice. China has a large population and diverse diseases,but chinical disease research relevant policies and regulations are imperfect. In contrast,the United States has perfect laws and regulations related to clinical research. By comparatively analyzing the disease resource,platform support and regulatory environment between China and the U. S.,this article offers suggestions on the development of clinical research resources so as to facilitate the clinical research in China.