Issues in regulatory guidelines for data monitoring committees.
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.
DeMets
David
D
Department of Biostatistics and Medical Informatics, University of Wisconsin, 600 Highland Avenue, Box 4675, Madison, WI 53792-4675, USA. demets@biostat.wisc.edu
Califf
Robert
R
Dixon
Dennis
D
Ellenberg
Susan
S
Fleming
Thomas
T
Held
Peter
P
Julian
Desmond
D
Kaplan
Richard
R
Levine
Robert
R
Neaton
James
J
Packer
Milton
M
Pocock
Stuart
S
Rockhold
Frank
F
Seto
Belinda
B
Siegel
Jay
J
Snapinn
Steve
S
Stump
David
D
Temple
Robert
R
Whitley
Richard
R
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