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Updated: Jul 19, 2026

Selecting Multiple Biomarker Subsets with Similarly Effective Binary Classification Performances
Published on: October 11, 2018
A cost-effectiveness approach to the qualification and acceptance of biomarkers
Stephen A Williams1, David E Slavin, John A Wagner
1Global Clinical Technology, Pfizer Global Research and Development, 50 Pequot Avenue, New London, Connecticut 06342, USA. stephen.a.williams@pfizer.com
Abstract:
The flow of new medicines to patients depends on the development of new biomarkers and their correct interpretation, yet there are no widely accepted and practically applicable criteria that facilitate adequate biomarker qualification. As a result, case-by-case qualifications are based on subjective assessments that do not lead to optimal decisions for patients, which have contributed to the 'stagnation' in drug productivity identified by the FDA. An alternative is to qualify biomarkers in terms of cost effectiveness using a set of principles that enable the evaluation of biomarkers even with incomplete knowledge. This approach could minimize harm to patients, improve access to medicines and reduce healthcare costs.
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