Taking place in Washington, D.C. on March 8th, 2018, this public workshop will provide an opportunity for the stakeholder community to continue discussions around key challenges related to IND reporting practices proposed in the FDA guidance “Safety Assessment for IND Safety Reporting” issued in December 2015 . Sessions will highlight industry experience implementing these approaches, and discussion topics will include but not limited to safety assessment and aggregate analysis, as well as potential best practices for unblinding of data and trial integrity, identifying expected/anticipated events, and determining reporting thresholds.
ACI’s VP of Biometrics, Amit Bhattacharyya, will be serving on a panel discussing maintaining trial integrity with unblinding and clarifying the flexibility in choosing the entity responsible for aggregate analysis for IND safety reporting. This session will feature two presentations. The first presentation will consider the challenges related to the unblinding of data for safety assessment analyses, and whether trial integrity can be maintained with periodic unblinding by a group other than the DMC. The second presentation will focus on the intended functions of safety assessment committees (SACs) and whether such functions could be addressed through other bodies such as data monitoring committees (DMCs).
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