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A cost-effectiveness approach to the qualification and acceptance of biomarkers

Nature Reviews Drug Discovery volume 5, pages 897–902 (2006)Cite this article

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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Figure 1: Schematic showing a theoretical line of equal tolerability of risk (the 'iso-risk line'), along which the frequency and severity of harm are interchangeable.

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Author information

Authors and Affiliations

  1. Global Clinical Technology, Pfizer Global Research and Development, 50 Pequot Avenue, New London, 06342, Connecticut, USA

    Stephen A. Williams & Stephen A. Williams

  2. the Business Innovations Unit, Pfizer Global Research and Development, Ramsgate Road, Sandwich, CT13 9NJ, UK

    David E. Slavin

  3. the Department of Clinical Pharmacology, Merck Research Laboratories, PO BOX 2000, RY34-A548, 126 East Lincoln Avenue, Rahway, 07065, New Jersey, USA

    John A. Wagner

  4. Regulatory Strategy and Intelligence, Millennium Pharmaceuticals Inc., 40 Landsdowne Street, Cambridge, 02139, Massachusetts, USA

    Christopher J. Webster

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  1. Stephen A. Williams
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  2. David E. Slavin
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  4. Christopher J. Webster
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Corresponding author

Correspondence to Stephen A. Williams.

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Competing interests

S.A.W. and D.E.S. are employees of and stockholders in Pfizer, Inc. J.A.W. is an employee of and stockholder in Merck & Co. C.J.W. is an employee of and stockholder in Millennium Pharmaceuticals.

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Williams, S., Slavin, D., Wagner, J. et al. A cost-effectiveness approach to the qualification and acceptance of biomarkers. Nat Rev Drug Discov 5, 897–902 (2006). https://doi.org/10.1038/nrd2174

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