دورية أكاديمية
Toward implementing virtual control groups in nonclinical safety studies.
| العنوان: | Toward implementing virtual control groups in nonclinical safety studies. |
|---|---|
| المؤلفون: | Golden E; Center for Alternatives to Animal Testing (CAAT), Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA., Allen D; Inotiv, Inc., Morrisville, NC, USA., Amberg A; Sanofi, Preclinical Safety, Frankfurt, Germany., Anger LT; Genentech Inc., South San Francisco, CA, USA., Baker E; Physicians Committee for Responsible Medicine, Washington, DC, USA, Baran SW; VeriSim Life, San Francisco, CA, USA., Bringezu F; Merck Healthcare KGaA, Chemical & Preclinical Safety, Darmstadt, Germany., Clark M; Charles River Laboratories, now KALOS Technologies, Philadelphia, PA, USA., Duchateau-Nguyen G; Roche Pharmaceutical Research & Early Development, Pharmaceutical Sciences, Roche Innovation Center, Basel, Switzerland., Escher SE; Fraunhofer ITEM, Hannover, Germany., Giri V; BASF SE, Experimental Toxicology and Ecology, 67056 Ludwigshafen am Rhein, Germany., Grevot A; Novartis Institute for Biomedical Research, Novartis AG, Basel, Switzerland., Hartung T; Center for Alternatives to Animal Testing (CAAT), Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.; CAAT-Europe, University of Konstanz, Konstanz, Germany., Li D; Pfizer, Global Biometrics and Data Management, Groton, CT, USA., Lotfi L; Charles River Laboratories, Boston, MA, USA, Muster W; Roche Pharmaceutical Research & Early Development, Pharmaceutical Sciences, Roche Innovation Center, Basel, Switzerland., Snyder K; Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, USA., Wange R; Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, USA., Steger-Hartmann T; Bayer AG, Pharmaceuticals, Investigational Toxicology, Berlin, Germany. |
| المصدر: | ALTEX [ALTEX] 2024; Vol. 41 (2), pp. 282-301. Date of Electronic Publication: 2023 Dec 01. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Spektrum Akademischer Verlag Country of Publication: Germany NLM ID: 100953980 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1868-8551 (Electronic) Linking ISSN: 1868596X NLM ISO Abbreviation: ALTEX Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Heidelberg : Spektrum Akademischer Verlag, |
| مواضيع طبية MeSH: | Research*, Animals ; Control Groups ; Pharmaceutical Preparations |
| مستخلص: | 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. |
| فهرسة مساهمة: | Keywords: data sharing; historical control data; reduction of animal use; regulatory acceptance; statistical analysis Local Abstract: [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. |
| المشرفين على المادة: | 0 (Pharmaceutical Preparations) |
| تواريخ الأحداث: | Date Created: 20231203 Date Completed: 20240417 Latest Revision: 20240729 |
| رمز التحديث: | 20240729 |
| DOI: | 10.14573/altex.2310041 |
| PMID: | 38043132 |
| قاعدة البيانات: | MEDLINE |
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