哈佛医学院DF/HCC临床研究管理介绍--临床研究项目的“全流程”管理

Systematic introduction about clinical research management of HMS DF / HCC: entire process management of clinical research

临床研究是验证科学假设、提供循证医学证据、推动医学进步的必由之路。本文对哈佛医学院丹娜法伯/哈佛癌症中心(DF/HCC)临床研究的"全流程"中的研究立项前的法务咨询、研究设计、伦理审评,到启动后的监查、培训、安全与质量管理等方面进行系统介绍,可看出其管理体系已相当成熟。最后,分别从国内外临床研究管理的侧重点、管理环节、管理人员队伍和部门评价模式等4个方面进行差异比较。旨在通过借鉴和学习国外临床试验管理经验,在目前的基础上不断完善,为政策法规的制定提供一定依据,使医疗机构对临床研究的重视程度得到进一步提高,为国内临床研究行业发展提供参考。

Clinical research is the inevitable way to verify scientific hypothesis, providing evidence-based medicine and boost medical advancement. The entire process of clinical research in the Harvard Medical School af- filiated Dana-Farber Cancer Institute will be demonstrated in this article in terms of legal consulting prior to research project initiation, research design, ethical review, monitoring, training, quality control, etc. Apparently, this management system has been well established. Then, we would try to compare the foreign and domestic clinical re- search systems in four aspects including management priority, administration, administrative staffing and evaluation pattern of departments. By referring to and learning from the foreign experience of clinical research management, our current system could be further improved, the establishment of relevant law and policy could be expected, the role of clinical research would be valued more in the health system, and the entire clinical research industry in Chi- na would keep progressing.