Online Program Home
My Program

Abstract Details

Activity Number: 111 - Evidence Beyond Traditional Clinical Trials
Type: Invited
Date/Time: Monday, July 29, 2019 : 8:30 AM to 10:20 AM
Sponsor: Section on Medical Devices and Diagnostics
Abstract #300415 Presentation
Title: Propensity Score-Integrated Approaches for Incorporating Real-World Evidence in Clinical Studies
Author(s): Chenguang Wang*
Companies: John Hopkins University
Keywords: Real-World Evidence; Real-World Data; Regulatory review ; Propensity Score

Real-world data collected from medical products, including drugs, biological products and medical devices, are becoming "big" as a result of advances in biomedical science, information technology and engineering. High-quality real-world data can be transformed into scientific evidence for regulatory and healthcare decision makings using proven analytical methods and techniques. We introduce approaches both in frequentist and Bayesian paradigm that use propensity score methodology for leveraging real-world data in the design and analysis of clinical studies. Case studies are provided to demonstrate the proposals in the context of regulatory review. A software that implements the proposed methods is also illustrated.

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

Back to the full JSM 2019 program