Online Program Home
My Program

Abstract Details

Activity Number: 77 - Complex Designs and Composite Endpoints of Medical Device Clinical Studies and Benefit-Risk Analysis of Diagnostic Tests
Type: Contributed
Date/Time: Sunday, July 28, 2019 : 4:00 PM to 5:50 PM
Sponsor: Section on Medical Devices and Diagnostics
Abstract #301727 Presentation
Title: A Simulation of Various Missing Data Imputation Methods in the Application of Composite Endpoint
Author(s): Ja-An Lin* and Rajesh Nair and Natasha Sahr
Companies: FDA/CDRH and CDRH/FDA and St. Jude's Children's Hospital
Keywords: Composite Endpoint; Medical Device; Missing Data; Imputation

Composite endpoints often comes into play in the clinical study, when a single endpoint cannot comprehensively establish the effectiveness or safety profile of the proposed device well. A composite endpoint typically consists of several clinically relevant components. The components can be either from the effectiveness or safety perspective. Meanwhile, the types of component also can be categorical, continuous or survival. However, more data points need to be assessed, often means higher possibility for more missing data. To avoid the estimation bias due to missing data, the missing data imputation is usually suggested. To our understanding, it is not clear yet if the imputation directly to the composite endpoint or to the components instead lead to different conclusion. In this study, we conduct a simulation to investigate this issue with different commonly employed imputation methods. Hopefully the result provides insight to the researchers when adapting composite endpoints and selecting imputation method in the study.

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

Back to the full JSM 2019 program