The Totality of Evidence: Is More the Same as Better?

• Activity Number: 625
• Type: Invited
• Date/Time: Thursday, August 7, 2014 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Bruce Binkowitz*+ and Uma Kher
• Companies: Merck and Merck
• Keywords: cardiovascular ; recurrent event ; total events

Abstract

Analysis of time to first event is a long held tradition for trials in the cardiovascular area, including heart failure. Yet subjects in these studies can experience more than 1 event. Recent literature has focused on utilizing all events experienced by each subject as a way of increasing efficiency through having to enroll less subjects, use less investigator sites, and save money. Consideration for examining all events further extends to measuring total patient burden, cost effectiveness, and most importantly, capturing the best picture of a subject's condition and therefore the best potential therapy. This presentation will discuss how analyzing total events isn't as simple as designing a traditional time to first event study and, for example, running an Anderson-Gill extension to a Cox PH model on all events. Examples will be taken from actual trials including a trial examining subjects with acute decompensated heart failure.