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Session 6 – Blinding/Unblinding
Session Chair(s)
JP Clement, MD
Founder and Principal
JPCC Associates, United States
Mat Soukup, PhD
Deputy Director, Division of Biometrics VII, OB, OTS CDER
FDA, United States
Regulatory Authorities such as FDA and EMA provide directions or recommendations on reporting and unblinding clinical trial safety reports to authorities, investigators and IRBs. While unblinding reports is key for identifying any change in the safety profile of an investigational drug, it is important to balance between the need for maintaining trial integrity and identifying and alerting on any potential safety issue. The session will provide practical aspects and perspectives from industry leaders and data monitoring committees on the applied implementation of the different guidances and recommendations.
Speaker(s)
How to Monitor Safety in Blinded Clinical Trials
Brenda Crowe, PhD
Eli Lilly and Company, United States
Associate Vice President, Statistics
Statistical Approaches to Looking at Blinded Data and Detecting Signals
Greg Ball, PhD
ASAPprocess, United States
Safety Data Scientist
Perspective from a DMC
Janet Turk Wittes, PhD
Statistics Collaborative Inc., United States
President
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