Sponsor-CRO Practices That Facilitate the Creation of a High-Quality Pathology Report

Abstract

Contract research organizations (CROs) provide a multitude of valuable services and expertise to the pharmaceutical industry, government, and other organizations. One of those services is conducting nonclinical toxicology studies to assess the safety of chemical and biological entities intended as pharmaceuticals. An integral part of these studies is the generation and interpretation of pathology data. Both the CROs and the sponsors of these studies have a genuine interest in ensuring that the pathology data are accurate and that the reports are of high quality. The goal of this article is to provide the sponsors’ perspectives on practices that affect the conduct of preclinical studies and that specifically facilitate sound technical and scientific execution for pathology components of those studies, leading to the creation of pathology reports of high quality. This perspective will be limited to topics that affect the pathology contributor report of toxicology studies covered by Good Laboratory Practices (GLP) and will not encompass every possible aspect of the sponsor-CRO relationship. The sponsor-CRO relationship must be a collaborative and nonadversarial relationship that balances the perspectives and needs of both CROs (Gosselin et al. 2011) and sponsors. The success of this relationship and the generation of a pathology report of high quality will greatly depend on thorough communication at all stages of a toxicology study. The peer review process provides the opportunity for a comprehensive review of pathology data by a second pathologist to ensure that all test article– related target organs and findings are accurately and consistently identified, diagnosed, interpreted, and scored. For the purposes of this article, the study pathologist and the peer review pathologist are generally assumed to be employees of the CRO and sponsor, respectively. However, situations in which the study pathologist and/or the peer review pathologist are not employees of the CRO or the sponsor will require even closer communication between the CRO and the sponsor.