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Activity Number: 459 - Rethinking Intercurrent Events and Estimators Within the ICH E9(R1) Estimand Framework
Type: Topic Contributed
Date/Time: Wednesday, July 31, 2019 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #306486
Title: Estimands in Clinical Trials with Intercurrent Events
Author(s): Shanthi Sethuraman* and Yongming Qu and Linda Shurzinske
Companies: Eli Lilly and Company and Eli Lilly and Company and Eli Lilly and Company
Keywords: estimand; intercurrent; unobserved response; demonstrable; confounded

Randomized Controlled Trials (RCT) are the gold standard for evaluation of the efficacy and safety of investigational intervention (eg: drugs, biologics, devices).Efforts are typically made to ensure that all patients who participate in RCTs adhere to the assigned treatment and complete the studies. However, often some post-baseline factors prevent patients from completing the designed treatment. These factors called intercurrent events,include unsatisfactory efficacy, adverse events, or other reasons not related to the treatments’ efficacy and safety. These events either result in non-compliance with the study intervention, and/or use of additional medications due to unsatisfactory efficacy. Such events would either create unobserved responses, or result in responses not reflecting the originally designed intervention, referred to as confounded responses in this talk. The original ITT concept was intended to define the analysis patient population but not to handle the confounded or unobserved responses. Most discussions focus on handling the missing values and not confounded responses. This presentation provides an approach (Demonstrable Estimand) to address both types of response

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

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