Biomarkers and surrogate end points for fit-for-purpose development and regulatory evaluation of new drugs.
A consistent framework for the acceptance and qualification of biomarkers for regulatory use is needed to facilitate innovative and efficient research and subsequent application of biomarkers in drug development. One key activity is biomarker qualification, a graded, "fit-for-purpose" evidentiary process linking a biomarker with biology and clinical end points. A biomarker consortium model will distribute cost and risk, and drive efficient execution of research and ultimately regulatory acceptance of biomarkers for specific indications.
Wagner
J A
JA
Merck & Co. Inc., Rahway, New Jersey, USA. wagner@merck.com
Williams
S A
SA
Webster
C J
CJ
D015415:Biomarkers; D003657:Decision Making; D004341:Drug Evaluation / Q000379:methods*; D023381:Endpoint Determination; D006801:Humans; D015203:Reproducibility of Results; D012107:Research Design; D016896:Treatment Outcome
D015415:Biomarkers