title: Issues in regulatory guidelines for data monitoring committees.
abstract: As clinical trials have emerged as the major research method for evaluating new interventions, the process for monitoring intervention safety and benefit has also evolved. The Data Monitoring Committee (DMC) has become the standard approach to implement this responsibility for many Phase III trials. Recent draft guidelines on the operation of DMCs by the Food and Drug Administration (FDA) have raised issues that need further clarification or discussion, especially for industry sponsored trials. These include, the time when DMCs are needed, the role of the independent statistician to support the DMC, and sponsor participation at DMC meetings. This paper provides an overview of these issues, based on the discussions at the January, 2003 workshop sponsored by Duke Clinical Research Institute.
authors.affiliation: Department of Biostatistics and Medical Informatics, University of Wisconsin, 600 Highland Avenue, Box 4675, Madison, WI 53792-4675, USA. demets@biostat.wisc.edu
authors.forename: David
authors.initials: D
authors.lastname: DeMets
authors.forename: Robert
authors.initials: R
authors.lastname: Califf
authors.forename: Dennis
authors.initials: D
authors.lastname: Dixon
authors.forename: Susan
authors.initials: S
authors.lastname: Ellenberg
authors.forename: Thomas
authors.initials: T
authors.lastname: Fleming
authors.forename: Peter
authors.initials: P
authors.lastname: Held
authors.forename: Desmond
authors.initials: D
authors.lastname: Julian
authors.forename: Richard
authors.initials: R
authors.lastname: Kaplan
authors.forename: Robert
authors.initials: R
authors.lastname: Levine
authors.forename: James
authors.initials: J
authors.lastname: Neaton
authors.forename: Milton
authors.initials: M
authors.lastname: Packer
authors.forename: Stuart
authors.initials: S
authors.lastname: Pocock
authors.forename: Frank
authors.initials: F
authors.lastname: Rockhold
authors.forename: Belinda
authors.initials: B
authors.lastname: Seto
authors.forename: Jay
authors.initials: J
authors.lastname: Siegel
authors.forename: Steve
authors.initials: S
authors.lastname: Snapinn
authors.forename: David
authors.initials: D
authors.lastname: Stump
authors.forename: Robert
authors.initials: R
authors.lastname: Temple
authors.forename: Richard
authors.initials: R
authors.lastname: Whitley
mesh_terms: D026661:Clinical Trials Data Monitoring Committees / Q000458:organization & administration / Q000592:standards*; D002986:Clinical Trials as Topic; D017408:Guidelines as Topic; D006801:Humans; D012109:Research Support as Topic; D014481:United States; D014486:United States Food and Drug Administration