哈佛医学院DF／Hcc临床研究管理介绍--临床研究的“中心化”管理

Systematic introduction of DF/HCC-centralized management of clinical research in the Harvard Medical School

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。本文通过对哈佛医学院丹娜法伯/哈佛癌症中心(DF/HCC)4个中心化管理的临床研究办公室(涉人研究保护办公室、临床研究质量保证办公室、临床研究培训办公室和合同管理办公室)以及6个关键环节(临床研究的科学设计、组织、安全监管、质量管理、事务协调以及风险控制和赔偿)的详细介绍,将哈佛系统临床研究管理平台的运作和管理模式进行深入剖析。最后,从研究者发起临床研究(IIT)的管理平台建立程度、临床研究关键环节的管控以及风险评估和赔偿机制3个方面的异同对国内外现状进行了对比。希望通过借鉴和学习国外的临床试验管理经验,在目前的基础上不断完善,为国内从事临床研究管理的同行提供一个了解国外管理经验的途径,使医疗机构对临床研究的管理更加系统和完善,对国内的临床研究行业发展带来一定帮助。

Clinical research is the inevitable way to verify scientific hypothesis, provides evidence-based medicine and boosts medical advancement. In the current paper, the operation and administration of clinical re- search management platform in the Harvard Medical School affiliated Dana-Farber Cancer Institute （DF/HCC） will be demonstrated in detail, which includes four centralized clinical research offices （Office for Human Research Studies, Quality Assurance Office for Clinical Trials, Clinical Trials Education Office and Clincal Trials Agreement Office） and six critical processes （Scientific Design, Organization, Safety Supervision, Quality Control, Coordina- tion, Risk Control and Compensation）. Finally, the foreign and domestic clinical research management systems would be compared promptly in terms of administrative platform establishment in the investigator initiated trials （liT）, supervision in the critical processes of clinical research, risk estimation and compensation. By referring to and learning from the foreign experience of clinical research management, our current system could be further im- proved, the advanced oversea experience could be shared with our administrative staff of clinical research in China, the management of clinical research in health system could be more systematic and perfected, and the entire clinical research industry would keep progressing.