The Role of the Peer Review Pathologist in Good Laboratory Practices Studies: A Sponsor Perspective

While the study pathologist (SP) signs the pathology report and is ultimately accountable for the data, the sponsor peer review pathologist (SPRP) generally signs a peer review (PR) statement indicating agreement with the overall pathology data and the associated interpretations. Additionally, the SPRP is often the initial contact to field internal and regulatory pathology data queries. Therefore, the SPRP should conduct as comprehensive a pathology PR as necessary to have complete confidence in the data and interpretations. Ideally, the SPRP should be involved at study design, as the study evolves, through completion of the overall study report. The SPRP should prepare as much as possible before the actual PR start date to include a review of all available data that may impact the PR. This review should focus on identifying findings not already identified in the draft pathology report that may need further interrogation. While all discrepancies between the SPRP and SP may be discussed for mutual learning, the emphasis should be on resolving issues that impact study interpretation. The final pathology report should reflect the consensus between the SP and SPRP and appropriately communicate the study findings. This article provides further background and example scenarios to illustrate these PR perspectives.