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Toward implementing virtual control groups in nonclinical safety studies : Workshop report and roadmap to implementation

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2023

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Golden, Emily
Allen, David
Amberg, Alexander
Anger, Lennart T.
Baker, Elizabeth
Baran, Szczepan W.
Bringezu, Frank
Clark, Matthew
Steger-Hartmann, Thomas
et al.

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Alternatives to Animal Experimentation : ALTEX. Springer. 2023, 41(2), S. 282-301. ISSN 1868-596X. eISSN 1868-8551. Verfügbar unter: doi: 10.14573/altex.2310041

Zusammenfassung

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 entirely replace the concurrent control group. This would constitute a substantial contribution to the reduction of animal use in safety studies. Before the concept can be implemented, the prerequisites regarding data collection, curation, and statistical evaluation together with a validation strategy need to be identified to avoid any impairment of the study outcome and subsequent consequences for human risk assessment. To further assess and develop the concept of virtual control groups, the transatlantic think tank for toxicology (t4) sponsored a workshop with stakeholders from the phar­maceutical and chemical industry, academia, FDA, contract research organizations (CROs), and non-governmental organizations in Washington, which took place in March 2023. This report sum­marizes the current efforts of a European initiative to share, collect, and curate animal control data in a centralized database and the first approaches to identify optimal matching criteria between virtual controls and the treatment arms of a study as well as first reflections about strategies for a qualifi­cation procedure and potential pitfalls of the concept.

Plain language summary: Animal safety studies are usually performed with three test groups of animals where increasing amounts of the test chemical are given to the animals and one control group where the animals do not receive the test chemical. The design of such studies, the characteristics of the animals, and the measured parameters are often very similar from study to study. Therefore, it has been suggested that measurement data from the control groups could be reused from study to study to lower the total number of animals per study. This could reduce animal use by up to 25% for such standardized studies. A workshop was held to discuss the pros and cons of such a concept and what would have to be done to implement it without threatening the reliability of the study outcome or the resulting human risk assessment.

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570 Biowissenschaften, Biologie

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data sharing, reduction of animal use, statistical analysis, historical control data, regulatory acceptance

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ISO 690GOLDEN, Emily, David ALLEN, Alexander AMBERG, Lennart T. ANGER, Elizabeth BAKER, Szczepan W. BARAN, Frank BRINGEZU, Matthew CLARK, Thomas HARTUNG, Thomas STEGER-HARTMANN, 2023. Toward implementing virtual control groups in nonclinical safety studies : Workshop report and roadmap to implementation. In: Alternatives to Animal Experimentation : ALTEX. Springer. 2023, 41(2), S. 282-301. ISSN 1868-596X. eISSN 1868-8551. Verfügbar unter: doi: 10.14573/altex.2310041
BibTex
@article{Golden2023Towar-70123,
  year={2023},
  doi={10.14573/altex.2310041},
  title={Toward implementing virtual control groups in nonclinical safety studies : Workshop report and roadmap to implementation},
  number={2},
  volume={41},
  issn={1868-596X},
  journal={Alternatives to Animal Experimentation : ALTEX},
  pages={282--301},
  author={Golden, Emily and Allen, David and Amberg, Alexander and Anger, Lennart T. and Baker, Elizabeth and Baran, Szczepan W. and Bringezu, Frank and Clark, Matthew and Hartung, Thomas and Steger-Hartmann, Thomas}
}
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Plain language summary:
Animal safety studies are usually performed with three test groups of animals where increasing amounts of the test chemical are given to the animals and one control group where the animals do not receive the test chemical. The design of such studies, the characteristics of the animals, and the measured parameters are often very similar from study to study. Therefore, it has been suggested that measurement data from the control groups could be reused from study to study to lower the total number of animals per study. This could reduce animal use by up to 25% for such standardized studies. A workshop was held to discuss the pros and cons of such a concept and what would have to be done to implement it without threatening the reliability of the study outcome or the resulting human risk assessment.</dcterms:abstract>
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