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.

Author affiliations

1. Stephen A. Williams is in Global Clinical Technology, Pfizer Global Research and Development, 50 Pequot Avenue, New London, Connecticut 06342, USA
2. David E. Slavin is in the Business Innovations Unit, Pfizer Global Research and Development, Ramsgate Road, Sandwich, CT13 9NJ, UK
3. John A. Wagner is in the Department of Clinical Pharmacology, Merck Research Laboratories, PO BOX 2000, RY34-A548, 126 East Lincoln Avenue, Rahway, New Jersey 07065, USA.
4. Christopher J. Webster is in Regulatory Strategy and Intelligence, Millennium Pharmaceuticals Inc., 40 Landsdowne Street, Cambridge, Massachusetts 02139, USA.

Correspondence to: Email: stephen.a.williams@pfizer.com

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