A generic operational strategy to qualify translational safety biomarkers
Matheis K, Laurie D, Andriamandroso C, Arber N, Badimon L, Benain X, Bendjama K, Clavier I, Colman P, Firat H, Goepfert J, Hall S, Joos T, Kraus S, Kretschmer A, Merz M, Planatscher H, Schneiderhan-Marra N
Drug Discov Today. 2011 July; 16(13-14): 600-608. DOI 10.1016/j.drudis.2011.04.011
The importance of using translational safety biomarkers that can predict, detect and monitor drug-induced toxicity during human trials is becoming increasingly recognized. However, suitable processes to qualify biomarkers in clinical studies have not yet been established. There is a need to define clear scientific guidelines to link biomarkers to clinical processes and clinical endpoints. To help define the operational approach for the qualification of safety biomarkers the IMI SAFE-T consortium has established a generic qualification strategy for new translational safety biomarkers that will allow early identification, assessment and management of drug-induced injuries throughout R&D.