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Activity Number: 110 - Assessing Treatment Effects for Life History Processes
Type: Topic Contributed
Date/Time: Monday, July 30, 2018 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #330987 Presentation
Title: Assessment of a Treatment Effect for Recurrent Event Data in the Presence of a Terminal Event
Author(s): Philip Hougaard*
Companies: Lundbeck
Keywords: recurrent events; frailty; estimands; terminal events

The paper considers clinical trials where multiple occurrences of the same event are recorded over time. I will first consider the case without terminal events, focusing on, the Poisson and the frailty-Poisson model, with a proportional hazards assumption. The frailty-Poisson model shows the same treatment effect unconditionally as conditionally on the frailty. From this we will learn that studying the first event only is insufficient because the unconditional effect is smaller than the conditional. We will also learn that a rate model may target the same treatment effect as the frailty model. Terminal events make the case more complicated because events cannot occur after death and therefore we need to be concerned whether any suggested analysis technique could make a treatment with high mortality appear as successful in reducing the number of events. The suggestion is to consider the integrated hazard of events even though this probably falls outside the estimand definition.

Authors who are presenting talks have a * after their name.

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