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Activity Number: 55 - Non-Proportional Hazards in Clinical Trials: Challenges and Opportunities
Type: Topic Contributed
Date/Time: Sunday, July 29, 2018 : 4:00 PM to 5:50 PM
Sponsor: Section on Statistical Graphics
Abstract #329894
Title: Case Studies of Non-Proportional Hazards in Oncology and Hematology Trials
Author(s): Jingjing Ye*
Companies: FDA
Keywords: Non-proportional Hazard; Oncology; Hematology; Registration trial

Time-to-event endpoints are typically used as primary or key secondary endpoints in registration oncology and hematology trials. Non-proportional hazards present frequently in oncology and hematology trials due to many reasons and/or different mechanism of actions of the drugs. For example, survival curves in randomized immunotherapy trials can show a delayed separation between treatments, and this implies non-proportional hazards of the survival curves. In this presentation, we present several case studies of the oncology and hematology trials that non-proportional hazards are observed. We will show simulation results and also examine and compare methods for evaluating efficacy when non-proportional hazards present.

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

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