Could a phase model help to improve translational animal research?
Abstract Background Animal models are widely applied in medical research for different purposes. In particular, results from translational experiments may be used for subsequent clinical development. However, transferability of these findings to the human organism is controversial. Among other facto...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
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Wiley
2022-12-01
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| Series: | Animal Models and Experimental Medicine |
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| Online Access: | https://doi.org/10.1002/ame2.12284 |
| _version_ | 1797979324197896192 |
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| author | Benjamin Mayer Jan Tuckermann Rainer Muche |
| author_facet | Benjamin Mayer Jan Tuckermann Rainer Muche |
| author_sort | Benjamin Mayer |
| collection | DOAJ |
| description | Abstract Background Animal models are widely applied in medical research for different purposes. In particular, results from translational experiments may be used for subsequent clinical development. However, transferability of these findings to the human organism is controversial. Among other factors, this may be traced back to a lack of clear differentiation of the evidence (explorative vs. confirmatory) provided by such experimental results. In general, inferential statistics (i.e. p values) should not be interpreted in as confirmatory unless crucial methodological requirements are met. Methods Therefore, we propose a phase model which reflects the well‐established process of clinical research, and we discuss its potential to improve decision making in translational research. The model aims to clarify the reliability of results derived from animal models. Results The phase model proposes subdividing translational, pre‐clinical research into pilot, exploration, and confirmation phases. Experiments for which there is no valid estimation of the expected effect size are designated as pilot studies. Based on these data, experiments in subsequent phases may be planned using both appropriate design and statistical methods. Conclusion Separating the entire process of translational animal research into three phases could contribute to improved transparency of the evidence derived from such experiments. |
| first_indexed | 2024-04-11T05:37:13Z |
| format | Article |
| id | doaj.art-a6896328d2f749c9a4a4a0e99662bc3e |
| institution | Directory Open Access Journal |
| issn | 2576-2095 |
| language | English |
| last_indexed | 2024-04-11T05:37:13Z |
| publishDate | 2022-12-01 |
| publisher | Wiley |
| record_format | Article |
| series | Animal Models and Experimental Medicine |
| spelling | doaj.art-a6896328d2f749c9a4a4a0e99662bc3e2022-12-22T11:50:43ZengWileyAnimal Models and Experimental Medicine2576-20952022-12-015655055610.1002/ame2.12284Could a phase model help to improve translational animal research?Benjamin Mayer0Jan Tuckermann1Rainer Muche2Institute of Epidemiology and Medical Biometry Ulm University Ulm GermanyInstitute of Comparative Molecular Endocrinology Ulm University Ulm GermanyInstitute of Epidemiology and Medical Biometry Ulm University Ulm GermanyAbstract Background Animal models are widely applied in medical research for different purposes. In particular, results from translational experiments may be used for subsequent clinical development. However, transferability of these findings to the human organism is controversial. Among other factors, this may be traced back to a lack of clear differentiation of the evidence (explorative vs. confirmatory) provided by such experimental results. In general, inferential statistics (i.e. p values) should not be interpreted in as confirmatory unless crucial methodological requirements are met. Methods Therefore, we propose a phase model which reflects the well‐established process of clinical research, and we discuss its potential to improve decision making in translational research. The model aims to clarify the reliability of results derived from animal models. Results The phase model proposes subdividing translational, pre‐clinical research into pilot, exploration, and confirmation phases. Experiments for which there is no valid estimation of the expected effect size are designated as pilot studies. Based on these data, experiments in subsequent phases may be planned using both appropriate design and statistical methods. Conclusion Separating the entire process of translational animal research into three phases could contribute to improved transparency of the evidence derived from such experiments.https://doi.org/10.1002/ame2.12284confirmatory trialshypothesis testingresults interpretationtransferability |
| spellingShingle | Benjamin Mayer Jan Tuckermann Rainer Muche Could a phase model help to improve translational animal research? Animal Models and Experimental Medicine confirmatory trials hypothesis testing results interpretation transferability |
| title | Could a phase model help to improve translational animal research? |
| title_full | Could a phase model help to improve translational animal research? |
| title_fullStr | Could a phase model help to improve translational animal research? |
| title_full_unstemmed | Could a phase model help to improve translational animal research? |
| title_short | Could a phase model help to improve translational animal research? |
| title_sort | could a phase model help to improve translational animal research |
| topic | confirmatory trials hypothesis testing results interpretation transferability |
| url | https://doi.org/10.1002/ame2.12284 |
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