|
Abstract:
|
Data monitoring committees (also called Data and Safety Monitoring Boards) have been components of the clinical trials oversight process for half a century. Initially, such committees were established only for a very limited number of trials, primarily those sponsored by the National Institutes of Health. Over time, use of such committees became more frequent, especially after the NIH established a policy in 1998 that NIH-sponsored randomized clinical trials were required to have such oversight. Over the years, consensus has developed on many aspects of DMC operations, but some issues remain controversial. Areas of discussion and/or change include the appropriate roles of study sponsors and trial investigators in DMC meetings; DMC meeting format; presentation of interim comparisons to the DMC with actual treatment groups versus coded treatment groups; use of sequential designs to guide early termination decisions; the types of data presented at DMC meetings; and most recently, the role of the DMC in trials using adaptive designs, and concerns about legal liability of DMC members.
|
