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Updated: Jun 14, 2026

Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis
Published on: March 20, 2021
Parallel paths to predictive biomarkers in oncology: Uncoupling of emergent biomarker development and phase III trial
1Amgen, Thousand Oaks, CA 91320, USA. public@robertsikorski.com
Abstract:
It is within pivotal phase III clinical trials that predictive biomarkers have the greatest potential to affect clinical practice by targeting drugs under development to relevant patient subgroups. Predictive biomarkers can be integrated into phase III clinical trials by a variety of approaches, including trial designs that uncouple the processes and actively anticipate the emergence of new biomarkers during trial execution. Here we describe the various approaches in an oncology context.
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