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The Ugly Truths of Today’s DMCs – and What the SDAC Can Do to Help

Primary: David Kerr
Author(s): David . Kerr
Axio Research

SCT Annual Meeting 2018

Abstract:
Background: Data Monitoring Committees (DMCs) are an important component of the clinical trial process. They are charged with reviewing interim data and making recommendations to protect the safety of trial participants and ensure the scientific integrity of the study. DMCs in practice are not performing as effectively as they should be. A real-world assessment will be provided of today’s DMC environment as well as suggestions for improvements that can be led by the SDAC (Statistical Data Analysis Center). Methods: The author is a leader of a Contract Research Organization (CRO) that specializes in providing independent DMC services for government and industry sponsored trials. He has worked with over a hundred unique DMCs and facilitated approximately 500 DMC meetings. He will discuss the ugly truths about today’s DMCs, but provide insight into how an SDAC can be an agent for improving the DMC process. Results: Topics that will be covered include: • Ugly truths of today’s DMCs – DMC, Sponsor, and SDAC all can be guilty of sub-optimal performance • Key outputs that should be provided to DMCs • Successful approaches for the SDAC to assist the DMC through the outputs • Training the SDAC team • Prepping the SDAC before the DMC meeting • Intangibles for facilitating a quality DMC meeting • Useful SOPs for an SDAC • SDAC training potential or current DMC members • Examples of tricky SDAC/DMC interactions • Some final truths Conclusions: DMCs will perform a more thorough and efficient review with assistance from a skilled SDAC. An improved DMC process will better protect the safety of the trial participants and the validity of study results.

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