TL43: Safety Monitoring of Events of Interest and Alert Rules
*Bradley McEvoy, CDER, FDA  Elena Polverejan, Janssen R&D, Johnson&Johnson 

Keywords: safety, alert rules, IDMC

Safety events of interest could be specific to a drug or a class of drugs. Unblinded safety monitoring of events of interest in a drug development program is performed by an Independent Data Monitoring Committee (IDMC). Pre-defined alert criteria could be developed to aid the IDMC in the identification of a potential clinically relevant increase in the event risk associated with the drug versus a selected control. The definition of the alert criteria could be shared and agreed with regulatory agencies. If alert criteria are met, the IDMC would communicate this to the sponsor who in turn could notify health authorities (according to the set agreements), together with IDMC’s recommendation regarding the study or the program. The alert criteria need to have good operating characteristics, i.e. reasonably high probability of detecting a clinically meaningful increase in the event risk versus control, while controlling the probability of detecting a false positive signal. The participants will share their views and experience on this topic. Key Discussion Questions: - What type of alert rules could be defined? Any experience? - How could the operating characteristics of the alert rules be assessed? - How does IDMC operate regarding the alert rules?