目的 探讨如何在临床试验中建立数据与安全监察委员会(DSMB)以及数据与安全监察委员会应该如何履行其职责。方法 依托丹红注射液Ⅳ期临床试验平台,根据美国FDA发布的《临床试验数据监查委员会的建立与工作技术指导原则》的要求,并结合丹红注射液的研究目的、方案设计以及数据与安全监察委员会赋予的职责,制定了丹红注射液数据与安全监察委员会的章程与操作程序。结果 丹红注射液Ⅳ期临床试验建立了由临床医生、统计学家和生物伦理学家组成的独立数据与安全监察委员会。数据与安全监察委员会制定了相应的操作规则、工作职责和委员会章程。其主要通过召开不同形式的会议来履行工作职责,采用临床电子数据采集系统(EDC)集中监察和现场监察的方式对试验执行情况进行审查和评价,制定并开展相应的期中分析,重估样本量并对方案进行适应性调整,提高试验的成功率,从而更好的保护受试者的安全与利益,保证临床试验数据的真实性和可靠性,进一步提高临床试验质量的可控性。结论 数据与安全监察委员会的建立不仅能保护受试者的安全与利益,同时也能保证试验结果的科学性。丹红注射液Ⅳ期临床试验数据与安全监察委员会的工作情况可为其他临床研究建立数据与安全监察委员会提供参考。

OBJECTIVE The purpose of this paper is to introduce the establishment and operation of Clinical Trial Data and Safety Monitoring Board (DSMB). METHODS Based on the platform of Phase Ⅳ clinical trials for Danhong Injection, and the FDA guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees”, we made the rule and standard operating procedure of DSMB for Danghong Injection Phase Ⅳ clinical trials according to the purposes, study designs of the trials and the responsibilities of DSMB. RESULTS Independent DSMB has been established in the trials of Danhong injection. The members in DSMB included clinicians, statisticians and bioethicists. DSMB established the standard operating procedure, responsibilities and committee rules. DSMB mostly held different forms of meeting to perform its responsibilities. It evaluated the operation of the trials mostly through two ways: EDC system centralized monitoring and on-site inspection. It also formulated and carried out the interim analysis in certain times to revaluate the sample size, to improve the success rate of the trials. All above operations could better protect the safety and interests of the participants, ensure the authenticity and reliability of the clinical trial data and further improve the controllability on the quality of clinical trials. CONCLUSION DSMB could not only protect the safety and interests of the participants, but also ensure the scientificity of study outcomes. The establishment and operation of DSMB in Danhong Injection Phase Ⅳ trials takes a good example for other studies.