部分县级医院申请药物临床试验机构资格认定工作探讨

目的:探讨部分县级医院申请药物临床试验机构资格认定的可行性。方法:查阅相关法律法规及文献,总结我院在申请国家药物临床试验机构资格认定过程中遇到的有别于三级医院和需要特别重视的问题。结果:我院具备申请国家药物临床试验机构资格认定的条件和开展部分试验的能力,但也存在职工信心不足、符合申请条件的科室较少、规范意识和药物临床试验技能有待提高及伦理委员会起步晚、发展慢等问题。通过加强事先的调研、申请专业的遴选、《药物临床试验质量管理规范》和药物临床试验技能的培训及伦理委员会的建设,最终取得了药物临床试验机构资格认定。结论:相关部门批准部分县级医院开展药物临床试验,符合我国国情。

Research on Part of County-level Hospitals Applying for Qualification of Clinical Drug Trial Institution

OBJECTIVE：To investigate the feasibility of part of county-level hospital applying for the qualification of clinical drug trial institution. METHODS：Reviewing laws,regulations and literatures,the important problems,different from those third level hospitals faced,that our hospital may have faced in the process of application for national clinical drug trial institution were summarized. RESULTS：Our hospital met the requirements of national clinical drug trial institution and was capable to conduct some clinical drug trials. However,there were also some shortages,such as lack of confidence;only a few departments were qualified;consciousness of normalization and skills of clinical drug trial need to be improved;our ethics committee was still very young and growing slowly. Nevertheless,we finally succeeded in the application by enhancing prior survey,selections of majors,Good Clinical Practice（GCP）,training on clinical drug trial and related skills,and development of ethics committee. CONCLUSIONS：It is suitable to China＇s actual conditions that the relevant departments approve clinical drug trials in some county-level hospitals.