Accountability in Methodology and Analysis for Clinical Trials Involving Quantitative Measurements of MR Brain Images

Quantitative measurements of macroscopic neural anatomy that are obtained from MRI scans are beginning to be used in clinical trials. This paper describes procedures and software features that ensure the demonstrable validity of these measurements. In addition to describing mechanisms that provide data integrity and security throughout the image analysis pipeline, we present “SegMentor”, a system that provides accountability for neuroanatomical measurement techniques. Employing these methods results in neuromorphometrics that are suitable as surrogate endpoints for diagnosis and for measuring response to treatment.