The VICT3R project aims to replace the use of live animal control groups in animal studies with Virtual Control Groups based on high-quality historical control data.

The possibility of significantly reducing, especially the use of larger species like dogs and nonhuman primates, has generated a lot of interest in the project, which is now well underway.

A recently published paper (“IHI VICT3R: Developing and Implementing Control Groups to Reduce Animal Use in Toxicology Research”*) outlines the design of the control data workflow and how the control group database developed by grit42 sits at the core of the project.

The workflow revolves around 3 steps.

1. The transfer of SEND data

The first step is the transfer of SEND or SEND-like data from the LIMS of the participating pharma companies where this data currently sits. The data is transferred to a data lake for further processing.

2. Data transformation and standardization

The next step is all about ensuring the quality of the data. In this phase, the data is transformed, annotated, curated, and standardized in order to meet the requirements for storing it in the VICT3R database.

3. Control Group Database

The third step is transferring the data to the VICT3R Database designed to host vast amounts of control group data. From here, the data can first be used for exploratory data analysis (EDA) and visualisation and then the generation of Virtual Control Groups that match the exact needs of new animal toxicity studies.

So apart from storing data and making it easily accessible, the database will also be integrated with tools for data retrieval and mining, visualisation, and statistical analysis.

The control data workflow is depicted here:

The VICT3R database is built on top of the grit Science Data Management Platform, which has been refactored and the data model updated to serve the exact needs of the VICT3R project. The database is live (with data from an earlier prototype), and currently, 50 users are registered and actively working with it.

Next milestone: Upload of VICT3R-produced SEND dataset

The next important milestone for us in this project will be the upload of the first VICT3R-produced and curated SEND dataset coming out from the depicted process. Hence, data uploaded to the data lake, curated, standardised, and delivered to grit42 for incorporation into the VICT3R database. Following shortly after is the integration of EDA tools developed in R by some of the statistical experts in the project.

The VICT3R project runs until 2028. It’s funded by the Innovative Health Initiative Joint Undertaking (IHI JU) and has 33 partner organizations, including 20 industry leaders, 7 innovative small- and medium-sized enterprises, and 6 top-tier academic institutions.

The performance of the complete Virtual Control Group procedure will be assessed by comparing the outcome of existing studies before and after replacing the concurrent controls with VCGs. The results will be presented to a number of regulatory bodies globally (EMA & FDA EFSA, ECHA) to obtain feedback and, eventually, regulatory acceptance of the VCG concept.  

*Steger-Hartmann T, Sanz F, Bringezu F, Soininen I. IHI VICT3R: Developing and Implementing Virtual Control Groups to Reduce Animal Use in Toxicology Research. Toxicologic Pathology. 2024;0(0). doi:10.1177/01926233241303906