Some Statistical Method in Bridging Efficacy Studies for Companion Diagnostic Tests

• Activity Number: 333
• Type: Invited
• Date/Time: Tuesday, August 11, 2015 : 10:30 AM to 12:20 PM
• Sponsor: Section on Medical Devices and Diagnostics
• Author(s): Xiao-Hua Zhou*
• Companies: University of Washington
• Keywords: Bridging Studies ; Personalized Medicine ; Potential Outcomes ; Causal Inferences

Abstract

Personalized treatments are a new frontier of medical research because effectiveness of a drug may be related to patient molecular characteristics. Hence, companion diagnostic devices (CDx) are developed to detect these molecular characteristics so that targeted drugs may be developed. Due to time and logistics, it may not be possible to develop a CDx concurrently with the development of a new drug. Often, a clinical trial assay (CTA) is used in a pivotal clinical trial, which results in the relationship between CTA and the treatment effectiveness. In order to get the relationship between the CDx and the treatment effectiveness, we need to conduct a bridging study. In this talk, I discuss some statistical methods for analyzing data from a bridging study.