为临床试验设立数据监测委员会。
Establishing a data monitoring committee for clinical trials.
作者信息
Lin Julia Y, Lu Ying
机构信息
US Department of Veterans Affairs Cooperative Studies Program Coordinating Center, Palo Alto VA Health Care System, Palo Alto, CA, USA.
US Department of Veterans Affairs Cooperative Studies Program Coordinating Center, Palo Alto VA Health Care System, Palo Alto, CA, USA ; Department of Health Research and Policy, Stanford University School of Medicine, Stanford, CA, USA.
出版信息
Shanghai Arch Psychiatry. 2014 Feb;26(1):54-6. doi: 10.3969/j.issn.1002-0829.2014.01.009.
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.
数据监测委员会（DMC）是由研究主办方任命的一组临床医生和生物统计学家，他们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，食品药品监督管理局要求在所有评估新干预措施的试验中成立DMC。在其他存在重大安全问题、采用双盲治疗分配或预计会对临床实践产生重大影响的临床研究中，也强烈建议设立DMC。它们在精神病学临床研究中很重要，因为它们为这类研究中经常纳入的弱势群体提供了额外的保护。本报告描述了DMC的作用、组建和运作。
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