Aufgrund von Vorbereitungen auf eine neue Version von KOPS, können kommenden Montag und Dienstag keine Publikationen eingereicht werden. (Due to preparations for a new version of KOPS, no publications can be submitted next Monday and Tuesday.)
Type of Publication: | Journal article |
Publication status: | Published |
URI (citable link): | http://nbn-resolving.de/urn:nbn:de:bsz:352-2-14lk1jgxwugf40 |
Author: | Hartung, Thomas |
Year of publication: | 2013 |
Published in: | Alternatives to Animal Experimentation : ALTEX ; 30 (2013), 3. - pp. 275-291. - ISSN 0946-7785. - eISSN 1868-8551 |
DOI (citable link): | https://dx.doi.org/10.14573/altex.2013.3.275 |
Summary: |
Misled by animal studies and basic research? Whenever we take a closer look at the outcome of clinical trials in a field such as, most recently, stroke or septic shock, we see how limited the value of our preclinical models was. For all indications, 95% of drugs that enter clinical trials do not make it to the market, despite all promise of the (animal) models used to develop them. Drug development has started already to decrease its reliance on animal models: In Europe, for example, despite increasing R&D expenditure, animal use by pharmaceutical companies dropped by more than 25% from 2005 to 2008. In vitro studies are likewise limited: questionable cell authenticity, over-passaging, mycoplasma infections, and lack of differentiation as well as non-homeostatic and non-physiologic culture conditions endanger the relevance of these models. The standards of statistics and reporting often are poor, further impairing reliability. Alarming studies from industry show miserable reproducibility of landmark studies. This paper discusses factors contributing to the lack of reproducibility and relevance of pre-clinical research. The conclusion: Publish less but of better quality and do not rely on the face value of animal studies.
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Subject (DDC): | 570 Biosciences, Biology |
Keywords: | preclinical studies, animal studies, in vitro studies, toxicology, safety pharmacology |
Link to License: | Attribution 4.0 International |
Bibliography of Konstanz: | Yes |
HARTUNG, Thomas, 2013. Look back in anger : what clinical studies tell us about preclinical work. In: Alternatives to Animal Experimentation : ALTEX. 30(3), pp. 275-291. ISSN 0946-7785. eISSN 1868-8551. Available under: doi: 10.14573/altex.2013.3.275
@article{Hartung2013anger-41971, title={Look back in anger : what clinical studies tell us about preclinical work}, year={2013}, doi={10.14573/altex.2013.3.275}, number={3}, volume={30}, issn={0946-7785}, journal={Alternatives to Animal Experimentation : ALTEX}, pages={275--291}, author={Hartung, Thomas} }
Hartung_2-14lk1jgxwugf40.pdf | 542 |