TL38: Blinded Safety Assessment
Hal Li, Merck  *Sammy Yuan, Merck 

Keywords: FDA Guidance, Safety Assessment, Blinded Monitoring, Safety Signal Detection

In last Dec, FDA issued a new guidance on "Safety Assessment for IND Safety Reporting". An unsolved issue is the safety assessment when the study is still ongoing and data are blinded. Considerations need to be given on how to balance between the need to develop processes for evaluating unblinded data from ongoing trials and the need to preserve the scientific integrity of trial data. This round table will discuss such issues and focus on the blinded assessment of safety data, the statistical method to monitor the safety signals and determine a threshold, and the format of reporting the safety data blindly, etc, from both regulatory and sponsors’ perspective.