Despite much progress being made in recent years, one of the greatest challenges in the field of drug safety assessment is to reduce the number of animals used in in vivo toxicity studies. The eTRANSAFE project works towards this objective, pursuing the 3Rs approach to Replace, Reduce and Refine the number of animals used in drug safety evaluations.
One of the breakthroughs of the project is the revolutionary Virtual Control Groups (ViCoG) initiative, which has the potential to significantly reduce the number of animals by replacing concurrent control animals in toxicity studies with data collected from historical controls. More info about the concept here.
The ViCoG approach was recently presented in a joint meeting of IQ Pharma (BioSafe, DruSafe) and FDA on October 27th, 2022 gathering over 150 participants. The initiative was welcomed by both industry representatives and regulators and the path towards its implementation in toxicity studies was discussed. eTRANSAFE is currently planning to follow up these conversations in a workshop co-organized with the Center for Alternatives to Animal Testing (CAAT) in early Spring 2023.