Video-on-Demand Library

26 November 2024

Lea Vaas

The replacement of concurrent control animals by so-called Virtual Control Groups (VCGs) may reduce the use of animals in systemic toxicity studies and contributes to the 3R's principle of animal experimentation. However, the idea of replacing living beings with virtual data from historical data sets has so far not been introduced into the design of regulatory animal studies. Major steps facilitating review of methodology for derivation of ViCoGs from historical control data and performance testing in statistical analysis, are the collection, curation and sharing of suitable sets of historical control data from preclinical toxicity studies. This talk will summarize accomplished and ongoing efforts for cross-industry provision of data resources, standardization and curation activities and line out both general ideas and specific methodology for derivation of ViCoGs. Moreover, a discussion of advantages, pitfalls, real-world examples, potential solutions is given and ideas for transferring these insights into regulations and guidelines are presented.

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