Points to consider regarding the use and implementation of virtual controls in nonclinical general toxicology studies

The replacement of a proportion of concurrent controls by virtual controls in nonclinical safety studies has gained traction over the last few years. This is supported by foundational work, encouraged by regulators, and aligned with societal expectations regarding the use of animals in research. Thi...

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Published in:Regulatory toxicology and pharmacology 2024-06, Vol.150, p.105632-105632, Article 105632
Main Authors: Palazzi, Xavier, Anger, Lennart T., Boulineau, Theresa, Grevot, Armelle, Guffroy, Magali, Henson, Kristin, Hoepp, Natalie, Jacobsen, Matt, Kale, Vijay P., Kreeger, John, Lane, Joan H., Li, Dingzhou, Muster, Wolfgang, Paisley, Brianna, Ramaiah, Lila, Robertson, Nicola, Shultz, Valerie, Steger Hartmann, Thomas, Westhouse, Richard
Format: Article
Language:English
Subjects:
3Rs, animal use
Nonclinical
Toxicology
Virtual controls
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Summary:The replacement of a proportion of concurrent controls by virtual controls in nonclinical safety studies has gained traction over the last few years. This is supported by foundational work, encouraged by regulators, and aligned with societal expectations regarding the use of animals in research. This paper provides an overview of the points to consider for any institution on the verge of implementing this concept, with emphasis given on database creation, risks, and discipline-specific perspectives. •Implementing virtual controls needs careful preliminary work to design a quality database and digital microscopic slides.•Determining the covariates to select the virtual controls and respecting discipline-specific considerations is critical.•Compliance should be obtained via a stepwise validation process that will factor pre-identified risks.
ISSN:0273-2300
1096-0295
DOI:10.1016/j.yrtph.2024.105632