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Activity Number: 246 - New Mothods for Biomedical and Genetics Data
Type: Contributed
Date/Time: Monday, July 30, 2018 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #328484 Presentation
Title: Critical Steps for Composite Endpoint Analysis
Author(s): Jerry J. Li*
Companies: Merck & Co., Inc.
Keywords: Composite Endpoint; Data Analysis; Endpoint Derivations; Clinical Trials; Drug Development; Multiple Components
Abstract:

Composite endpoints have been widely used in clinical trials. A composite endpoint consists of multiple component endpoints that are combined for investigation assessment of drug treatment effect. Per ICH E9 guideline the selection of composite endpoints has been considered as an important strategy for registration of pharmaceuticals. When designed and analyzed appropriately, composite endpoints can have many advantages such as achieving study goals with smaller and less costly trials and improved statistical efficiency. On the other hand, misconstruction of a composite endpoint may make it difficult to analyze the endpoint and weaken the ability to reach a reliable conclusion. Critical steps of missing data handling and endpoints derivations will be discussed in this presentation to ensure accurate and efficient analyses of composite endpoints.


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

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