改善中国临床研究监管体系的几点建议

Advices on improving clinical research regulatory system in China

临床研究为人民健康生活的持续改善提供长期支持,同时也是发展医药创新产业的关键能力。未来医疗供给侧改革的重点之一,是满足未被满足的临床需求,这需要坚实的临床研究能力作为支撑。而纵观医药创新产业链,临床研究是无法替代的一步,也是投入时间和资源最多的阶段,是整个医药创新生态系统最为重要的环节。在这样的历史背景下,为了进一步推动中国临床研究体系的发展,7家协会和机构发起了专题研究,着力分析中国临床研究体系的现状和问题,探讨解决方案和路径。本文着重从监管体系角度分析目前临床研究的困难和挑战,并提出相关建议。

Clinical studies provide long-term support for the continuous improvements of people＇s healthy life,and it is also a key capability for the development of the pharmaceutical innovation industry. One of the focuses of the future medical supply-side reform is to meet unmet clinical needs,which requires strong clinical study capabilities as support. Throughout the pharmaceutical innovation industry chain,clinical research is an irreplaceable step,and it is also the most time-consuming and resource-consuming phase,which is the most important part of the entire pharmaceutical innovation ecosystem. In this historical background,in order to further promote the development of clinical study system in China,seven associations and institutions launched a special study to analyze the status quo and problems of clinical study system in China,and explore solutions and pathways. This paper focuses on the analysis of current difficulties and challenges of clinical study from the perspective of the regulatory system and provides recommendations accordingly.