Abstract Details
Activity Number:
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46
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Type:
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Invited
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Date/Time:
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Sunday, August 3, 2014 : 4:00 PM to 5:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #310717
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View Presentation
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Title:
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Data Monitoring Committee Oversight of Open Label Studies
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Author(s):
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Marian Fisher*+ and Kevin Buhr
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Companies:
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University of Wisconsin-Madison and University of Wisconsin-Madison
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Keywords:
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clinical trials ;
role of data monitoring committee (DMC) ;
post-marketing ;
open-label
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Abstract:
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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?
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Authors who are presenting talks have a * after their name.
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