Host: The Japanese Society of Toxicology
Name : The 50th Annual Meeting of the Japanese Society of Toxicology
Date : June 19, 2023 - June 21, 2023
Recently in clinical settings, studies in which it is difficult to recruit subjects, such as for rare diseases, or in which it is difficult to set up a control group from an ethical standpoint, are being conducted using historical controls generated from past clinical study data or real-world data. On the other hand, in non-clinical settings, as it is easier to set up control groups than in clinical studies and guidelines clearly state the necessity of setting up a negative control group, no attempt appears to have been made to set a control group (virtual control group: VCG) designed based on facility background data. However, from an ethical point of view toward test animals and issues in animal supply, introduction of VCG may contribute to reduction in the number of animals used. In this study, we examined the issues that arise when VCG is introduced into nonclinical toxicity studies. Specifically, we replaced the control group data in a previous repeated-dose toxicity study with VCG generated from the background data for additional statistical analysis, and interpreted the results obtained. This presentation shows the results of our interpretation and discusses the differences from studies in which normal control groups were used and points to take note of for each animal species when VCG is introduced into studies. Furthermore, we present our views on the introduction of VCG in qualitative data such as in histopathological examination. We also discuss issues that arise with the introduction of VCG for studies other than general toxicity studies.
