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Updated: Jul 29, 2026

Selecting Multiple Biomarker Subsets with Similarly Effective Binary Classification Performances
Published on: October 11, 2018
Optimizing the use of biomarkers, surrogate endpoints, and clinical endpoints for more efficient drug development
1MDS Harris Laboratories, 4639 South 36th Street, Phoenix, AZ 85040-2955, USA.
Abstract:
Biomarkers and surrogate endpoints are critical to the future of efficient drug development. Definitions, a conceptual model, and a conceptual framework for validating and bridging biomarkers to clinical endpoints are provided in this presentation. In addition, a few examples are provided to support the development concept. Poor correlation between a biomarker and its clinical endpoint may result from (1) poor measurement of one or both, (2) selection of an inappropriate biomarker, or, more important, (3) use of an inappropriate clinical endpoint. Pharmacokinetic/pharmacodynamic (PK/PD) modeling output can be no better than biomarkers or surrogate endpoints used for the modeling. As we increase our understanding of biomarkers, surrogate markers, and the mechanistic basis for the processes of interest, biomarker and surrogate endpoint predictive power will no longer be an issue and PK/PD modeling inputs and outputs will improve.
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