Peer-Reviewed Publication
ALTEX2024;41(2):282-301.January 1, 2024Journal Article
Toward implementing virtual control groups in nonclinical safety studies.
Emily Golden1, David Allen2, Alexander Amberg3, Lennart T Anger4, Elizabeth Baker5, Szczepan W Baran6, Frank Bringezu7, Matthew Clark8, Guillemette Duchateau-Nguyen9, Sylvia E Escher10, Varun Giri11, Armelle Grevot12, Thomas Hartung1,13, Dingzhou Li14, Laura Lotfi15, Wolfgang Muster9, Kevin Snyder16, Ronald Wange16, Thomas Steger-Hartmann17
1Center for Alternatives to Animal Testing (CAAT), Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
2Inotiv, Inc., Morrisville, NC, USA.
3Sanofi, Preclinical Safety, Frankfurt, Germany.
4Genentech Inc., South San Francisco, CA, USA.
5Physicians Committee for Responsible Medicine, Washington, DC, USA
6VeriSim Life, San Francisco, CA, USA.
7Merck Healthcare KGaA, Chemical & Preclinical Safety, Darmstadt, Germany.
8Charles River Laboratories, now KALOS Technologies, Philadelphia, PA, USA.
9Roche Pharmaceutical Research & Early Development, Pharmaceutical Sciences, Roche Innovation Center, Basel, Switzerland.
10Fraunhofer ITEM, Hannover, Germany.
11BASF SE, Experimental Toxicology and Ecology, 67056 Ludwigshafen am Rhein, Germany.
12Novartis Institute for Biomedical Research, Novartis AG, Basel, Switzerland.
13CAAT-Europe, University of Konstanz, Konstanz, Germany.
14Pfizer, Global Biometrics and Data Management, Groton, CT, USA.
15Charles River Laboratories, Boston, MA, USA
16Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, USA.
17Bayer AG, Pharmaceuticals, Investigational Toxicology, Berlin, Germany.
Abstract
Historical data from control groups in animal toxicity studies are currently mainly used for comparative purposes to assess validity and robustness of study results. Due to the highly controlled environment in which the studies are performed and the homogeneity of the animal collectives it has been proposed to use the historical data to build so-called virtual control groups, which could partly or…
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