Application of systematic reviews for transparent , objective and consistent test methods comparison to inform regulatory decisions about new test methods acceptance

New translational kidney safety biomarkers are now enabling drug development by: 1) enhancing safety monitoring of patients in early clinical trials for toxicities seen in animal studies that are of questionable human relevance, 2) providing early insights to pathogenic mechanisms leading to drug induced kidney injury in early drug development toxicology studies, and 3) assisting early compound selection and animal de-risking studies that reduce the probability of later attrition due to kidney toxicity. Several consortia including the FNIH Biomarker Consortium Kidney Safety Biomarker Project Team are presently collaborating on additional progressive qualification efforts in partnership with regulatory agencies and academia to further advance the qualification of novel translational renal safety biomarkers using samples from retrospective observational clinical studies in a learning mode, and prospectively designed confirmatory clinical studies. VII-1-829