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Activity Number: 644 - Statistical Methods for the Co-Development of Drug and Companion Diagnostic in Oncology
Type: Topic Contributed
Date/Time: Thursday, August 1, 2019 : 10:30 AM to 12:20 PM
Sponsor: Section on Medical Devices and Diagnostics
Abstract #306363 Presentation
Title: Logical Inference on Treatment Efficacy When Subgroups Exist
Author(s): Ying Ding*
Companies: University of Pittsburgh
Keywords: logical inference; personalized medicine; simultaneous confidence intervals; subgroup analysis; targeted therapy

With rapid advances in understanding of human diseases, the paradigm of medicine shifts from “one-fits-all” to targeted therapies. In targeted therapy development, the patient population is thought of as a mixture of two or more subgroups that may derive differential treatment efficacy. To ?nd the right patient population for the therapy to target, inference on treatment ef?cacy in subgroups as well as in the overall mixture population are all of interest. In this presentation, I will start by introducing two fundamental statistical issues in this inference procedure, followed by establishing a general logical estimation principle. Finally, as a step forward in patient targeting, we present a simultaneous inference procedure based on confidence intervals to logically infer treatment efficacy in subgroups and mixture of subgroups. Examples from oncology studies are used to illustrate the application of the proposed inference procedure.

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

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