Featured News
Revolutionizing the Future of Safety Studies
How Virtual Control Groups can reduce animal numbers in research
Virtual Control Groups (VCGs) have the potential to unlock a game-changing new design for safety assessment studies. We are embracing new approaches to enhance the way we serve customers to bring lifesaving therapies to patients and to further our 3Rs mission.
The use of VCGs is a testament to our commitment to our fourth R – Responsibility, which was developed specifically for Charles River. VCGs accelerate the drug discovery pathway and get much-needed therapies to patients faster.”
Laura Lotfi, Associated Director, Translational Science and Data Analytics
A Promising Tool for Reducing Animal Use
Animal candidates are selected from historical data to create a VCG based on study parameters to reduce the use of Concurrent Control Group (CCG) animals when feasible. VCGs database development uses an advanced analytics model to select and provide the best control-matched virtual animal to a targeted study design. Data science models and domain expertise are leveraged to statistically and biologically qualify and analyze VCG data when used on a CCG-targeted study.
Lay Proper Toxicology Groundwork for a Successful Preclinical IND Submission
Amid the shifting sands of preclinical drug development, general toxicology research remains the cornerstone of a successful IND program. Your sprint to market requires a solid foundation of informed planning and forward thinking. This webinar delves into the factors to consider when you’re laying the groundwork for your product’s safety profile.
Watch Now
VCGs are an established concept in clinical trials, but the idea of replacing concurrent live animals with virtual data sets has not yet been introduced into the design of regulatory nonclinical studies. In a usual animal study, approximately 25% of the animals are used as controls. The use of VCGs has the potential to reduce the number of animals needed for these studies by reusing the measurement data gathered from these control groups.
Although the concept of VCGs is in its early stages, significant progress has been made in this area. Before this approach can be fully implemented, the prerequisites around data collection, curation, and statistical evaluation paired with a validation strategy need to be identified to avoid compromising safety and study outcome reliability.
The Future of VCGs
The eventual implementation of VCGs will focus on a targeted study design with a partial replacement or hybrid approach, maintaining a reduced number of CCG animals and providing access to a curated matched control database. Since VCGs will be amenable for specific study designs, this will provide a continued updated stream to the VCG database.
With the feedback and insights gained from speaking with our sponsors, we are working on an iterative path forward to determine how best VCGs can safely reduce animal usage while continuing to ensure that patient safety is never compromised.”
Mark Mintz, Chief Information Officer
Continued efforts to further develop and qualify VCGs will be crucial for the advancement of animal welfare and the conduct of preclinical studies. With the depth of our client base, we are uniquely positioned to fuse the science of toxicology with machine learning for a powerful alternative to working with animals.