Topic of Histopathology Blinding in Nonclinical Safety Biomarker Qualification Studies

Various consortia and working groups, composed of profes-sionals from industry, academia, and government institutions, have undertaken or are undertaking nonclinical work to qualify safety biomarkers of tissue injury and function. As this work has developed and voluntary data have been submitted to reg-ulatory authorities, study practices have come under close scru-tiny in an attempt to ensure that the best science is consistently being applied. One practice that has been discussed in a variety of venues is the process used to generate histopathology data as additional end points and/or correlates in these studies. Histo-pathologic evaluation plays a critical role in these biomarker studies, because microscopic demonstration of given cellular processes are commonly used as a reference standard to assess diagnostic performance of candidate new biomarkers using methods such as receiver operating characteristic (ROC) anal