A cost-effectiveness approach to the qualification and acceptance of biomarkers.
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.
Williams
Stephen A
SA
Global Clinical Technology, Pfizer Global Research and Development, 50 Pequot Avenue, New London, Connecticut 06342, USA. stephen.a.williams@pfizer.com
Slavin
David E
DE
Wagner
John A
JA
Webster
Christopher J
CJ
D015415:Biomarkers / Q000032:analysis*; D003362:Cost-Benefit Analysis; D006801:Humans; D007880:Legislation, Drug; D010600:Pharmacology / Q000191:economics* / Q000639:trends*; D015203:Reproducibility of Results; D014481:United States; D014486:United States Food and Drug Administration
D015415:Biomarkers