Data Monitoring Committee Oversight of Open Label Studies

• Activity Number: 46
• Type: Invited
• Date/Time: Sunday, August 3, 2014 : 4:00 PM to 5:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Marian Fisher*+ and Kevin Buhr
• Companies: University of Wisconsin-Madison and University of Wisconsin-Madison
• Keywords: clinical trials ; role of data monitoring committee (DMC) ; post-marketing ; open-label

Abstract

Post-marketing trials are most often open-label, even those involving a randomized, parallel-group component. In double-blind, pre-marketing trials, the DMC has a clear role: ensuring subject safety and trial integrity by bringing relevant clinical and statistical expertise to bear on emerging treatment differences to which only they are privy. Their role in an open-label, post-marketing study is less clear. What purpose do they serve? What task do they perform that the sponsor cannot? What recommendations to stop or alter the trial (a post-marketing trial of an approved product!) can or should they make? This ambiguous role is further complicated by other aspects of the post-marketing context. For an open-label study, are DMC deliberations kept confidential from the sponsor and regulatory agencies, and, if so, why? Should data from pre-marketing trials for new indications be available to this DMC? Ultimately, is it enough that the DMC somehow provides "independent" oversight for post-marketing trials, and does this justify their involvement?