建立临床试验的数据监测委员会（英文）

Establishing a data monitoring committee for clinical trials

数据监测委员会是由研究赞助者指定的一组临床医生和生物统计学家,对临床试验的安全性、科学有效性和完整性进行独立评估。在美国,食品和药物管理局要求在评估所有新的干预时在要成立数据监测委员会。在其他临床研究中,如果存在重大的安全问题、实施双盲治疗分配或者预期对临床实践会产生重大影响,也强烈建议成立数据监测委员会。因为数据监测委员会对经常参加此类研究的弱势群体提供了一层额外的保护,所以他们在精神病学临床研究中是非常重要的。本报告描述了数据监测委员会的作用,组建和运作。

A data monitoring committee （DMC） is a group of clinicians and biostatisticians appointed by study sponsors who provide independent assessment of the safety, scientific validity and integrity of clinical trials. In the United States, the Food and Drug Administration requires the formation of DMC in all trials that assess new interventions. DMC are also strongly recommended in other clinical studies that have substantial safety issues, that have double-blind treatment assignment or that are expected to have a major impact on clinical practice. They are important in clinical research in psychiatry because they provide an added layer of protection for the vulnerable populations that are often enrolled in such studies. This report describes the role, formation and operation of DMC.