Scientific and Regulatory Policy Committee Points to Consider* for Determining and Reporting Cause of Death/Moribundity in Non-Rodent Species in Toxicity Studies

Abstract

The Cause of Death in Non-Rodents (CODN) Working Group is an initiative under the Scientific and Regulatory Policy Committee (SRPC) of the Society of Toxicologic Pathology (STP), focused on understanding existing practices and expectations among pharmaceutical companies, academic entities, and contract research organizations (CROs) when it comes to identifying and reporting the “Cause of Death” (COD) or moribundity for early or unplanned necropsies in non-rodent animal species (mainly non-human primates [NHP] and dogs) within both GLP (Good Laboratory Practice) and non-GLP toxicity studies. A survey was sent out to STP members to collect data on industry practices for determining COD in animals that underwent unscheduled euthanasia or were found deceased. Other non-rodent animals (such as pigs and rabbits) were also included to evaluate different approaches taken with various species. The insights obtained led to the development of “Points to Consider” for establishing and documenting the COD in large animal toxicity studies. Four key considerations include utilizing information from both control and treated animals in the study, consideration of COD for cohabiting or co-shipped non-study animals, including additional evaluations to help rule-in or rule-out specific causes, and recording the COD consistently in pathology databases or reports as a standard practice.