我国Ⅰ期临床研究中心现状分析

Status Analysis of Phase Ⅰ Clinical Research Center in China

目的为Ⅰ期临床研究中心的发展和建设提供一些参考建议。方法本研究通过文献资料法、数据对比分析法等方法,梳理了我国Ⅰ期临床研究中心相关法规政策,对中心建设数量、地区分布、床位数量,以及各中心承接Ⅰ期/BE临床研究现状等进行对比分析。结果发现我国Ⅰ期临床研究中心发展出现的新问题,包括Ⅰ期临床研究中心承接项目能力参差不齐,部分新建Ⅰ期临床研究中心资源浪费,一半以上Ⅰ期临床研究中心无新药Ⅰ期临床试验研究经验等。结论结合新政策下Ⅰ期临床研究中心面临的机遇与挑战,提出发展专业特色、合理进行资源配置、鼓励社会力量共建Ⅰ期临床研究中心3方面的建议。

OBJECTIVE To provide some suggestions for the development and construction of phaseⅠclinical research center in the future.METHODS The methods of literature review and data comparison analysis were used to comb the relevant regulations and policies of the phaseⅠclinical research center in China,to comparative analysis of the latest number of construction,regional distribution,the number of beds,and the current status of undertaking phaseⅠ/BE clinical study of each center.RESULTS It is found that the new problems in the development of phaseⅠclinical research centers in China are that the ability of phaseⅠclinical research centers to undertake projects is uneven,there is a waste of resources in some new phaseⅠclinical research centers,and more than half of the phaseⅠclinical research centers have no phaseⅠclinical trial research experience,etc.CONCLUSION Under the new policy,phaseⅠclinical research centers are facing with opportunities and challenges,the suggestions such as developing professional ability,reasonable resource allocation and encouraging social forces to build the phaseⅠclinical research center,can be used for developing and constructing phaseⅠclinical research centers.