Grevot, Armelle, Boisclair, Julie, Irizarry, Armando, Guffroy, Magali, Hall, Peter, Pohlmeyer-Esch, Gabriele, Jacobsen, Matt, Bach, Ute, Frisk, Ana Lena, Dybdal, Noel and Palazzi, Xavier (2024) Use of virtual control groups in nonclinical toxicity studies: the anatomic pathology perspective. Experimental and Toxicologic Pathology. ISSN 0192-62331533-1601

Abstract

In the last decade, numerous initiatives have emerged worldwide to reduce the use of animals in drug development, including more recently the introduction of Virtual Control Groups (VCGs) concept for nonclinical toxicity studies1. Although replacement of concurrent controls (CC) by virtual controls (VC’s) represents an exciting opportunity, there are associated challenges that will be discussed in this paper with a more specific focus on Anatomic Pathology. Coordinated efforts will be needed from toxicologists, clinical and anatomic pathologists, and regulators to support approaches that will facilitate a staggered implementation of VCGs in nonclinical toxicity studies required for submission of new drug candidates. Notably, the authors believe that a validated database for VC animals will need to include histopathology (digital) slides for microscopic assessment. The authors discuss a hybrid approach, whereby control groups are comprised of both concurrent and virtual controls in order to demonstrate proof of concept. Once confidence is established by regulators and sponsors, VC’s will replace some or all concurrent control animals.

Item Type:	Article
Keywords:	Virtual control, concurrent control, histopathology, whole slide imaging, digital pathology
Date Deposited:	24 Feb 2024 00:46
Last Modified:	24 Feb 2024 00:46
URI:	https://oak.novartis.com/id/eprint/51792