Online Program Home
My Program

Abstract Details

Activity Number: 46 - Recent Developments in Novel Clinical Trial Design and Analysis for Precision Medicine
Type: Invited
Date/Time: Sunday, July 28, 2019 : 4:00 PM to 5:50 PM
Sponsor: ENAR
Abstract #300173
Title: Designing Precision Medicine Trials in Oncology to Yield Greater Population Impact
Author(s): Michael LeBlanc* and Yingqi Zhao
Companies: Fred Hutchinson Cancer Research Center and Fred Hutchinson Cancer Research Center
Keywords: clinical trials; design; cancer; targeted ; treatment; efficacy

An important challenge in oncology clinical trials relates to designs to assess treatment efficacy in the context of treatments that target pathways and improved technologies to measure tumor biology. Current strategies for the evaluation of new treatments for cancer utilize designs that enrich(or target) for the population of patients who are thought to show the maximum treatment effect. We consider alternative study designs that instead target greater population impact maximizing the expected future patient outcomes both on and off the trial patients.

We show that data from Phase II trials can identify biomarker combinations and cutoffs to optimize the new objective function relating to future population impact. We then show that by conducting the follow-up phase III study using the proposed strategy, the population impact can be optimized. The proposed strategy is applicable to various types of responses, including continuous, binary and survival endpoints.

Our methods are tied to our experience in cancer our methods are tied to our experience in cancer clinical trials primarily through the SWOG Cancer Research Network and the NCI National Clinical Trials Network (NCTN).

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

Back to the full JSM 2019 program