Recurrent or Multiple Event Analyses in Cardiovascular Trials: Regulatory Experiences

• Activity Number: 625
• Type: Invited
• Date/Time: Thursday, August 7, 2014 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): H.M. James Hung*+
• Companies: FDA
• Keywords: cardiovascular ; renal ; major adverse clinical events ; hospitalization

Abstract

In cardiovascular or renal trials that we have seen in regulatory applications, major adverse clinical events are almost always assessed using analysis of time to first occurrence of the events. As some component events occur much more frequently, such as hospitalizations, during the trial, the analysis that includes all the events may improve statistical efficiency and capture disease burden of patients more properly. In this talk, I shall share a number of regulatory experiences with recurrent or multiple event analyses to give my insights into the possible values of such analysis and to stipulate the issues that need more attention.