Interim Analyses Workflow Optimization and Case Studies
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*Eric J. Silva, Cytel Inc. 

Keywords: interim analysis, dmc, adaptive design, dsmb

With the growing acceptance of adaptive trial designs, both sponsors and regulators are increasingly challenged to routinely manage and monitor trials incorporating interim analyses. This session will focus on identifying the challenges and the technology now being used to specifically address the demands inherent particularly with adaptive studies. We’ll examine new processes and online systems designed to preserve the integrity of the trial by securely managing access to the blinded data, supporting DMC procedures, facilitating audits, and automating analyses and reporting.