title: Establishing a data monitoring committee for clinical trials.
abstract: 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.
authors.affiliation: US Department of Veterans Affairs Cooperative Studies Program Coordinating Center, Palo Alto VA Health Care System, Palo Alto, CA, USA.
authors.forename: Julia Y
authors.initials: JY
authors.lastname: Lin
authors.affiliation: 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.
authors.forename: Ying
authors.initials: Y
authors.lastname: Lu
keywords: biostatistics; clinical trials; data monitoring committee; interim analysis
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