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Herausforderungen der Translation von innovativen Produkten und Technologien in die klinische Praxis

In times of increasing technicization and digitalization, the importance of translational medicine has increased. A successful translation from basic research to the clinical application is a costly and time-consuming process that depends on many factors. Negative examples from the past (thalidomide...

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Autores principales: Moser, Lukas B., Nehrer, Stefan, Angele, Peter, Aurich, Matthias, Dyrna, Felix, Hackl, Wolfgang, Hess, Silvan, Neubauer, Markus, Niemeyer, Philipp, Rupp, Marco-Christopher, Zellner, Johannes
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Medizin 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9972308/
http://dx.doi.org/10.1007/s00142-023-00593-3
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author Moser, Lukas B.
Nehrer, Stefan
Angele, Peter
Aurich, Matthias
Dyrna, Felix
Hackl, Wolfgang
Hess, Silvan
Neubauer, Markus
Niemeyer, Philipp
Rupp, Marco-Christopher
Zellner, Johannes
author_facet Moser, Lukas B.
Nehrer, Stefan
Angele, Peter
Aurich, Matthias
Dyrna, Felix
Hackl, Wolfgang
Hess, Silvan
Neubauer, Markus
Niemeyer, Philipp
Rupp, Marco-Christopher
Zellner, Johannes
author_sort Moser, Lukas B.
collection PubMed
description In times of increasing technicization and digitalization, the importance of translational medicine has increased. A successful translation from basic research to the clinical application is a costly and time-consuming process that depends on many factors. Negative examples from the past (thalidomide, metal-on-metal bearings in hip arthroplasty) show that translation also entails risks for the patient. In recent years, stricter requirements for the manufacture and approval of medical devices have been introduced to ensure patient safety. Autologous chondrocyte transplantation (ACT) is an example of successful translation. Preclinical experimental animal studies were followed by clinical patient studies with market approval and implementation in the routine clinical practice. The effectiveness of a product is not the only decisive factor in whether a product is approved for the market. Between the basic science and the willingness of the market to invest in the further development and commercialization of a product is a significant hurdle, which is also called the Valley of Death. The product will ultimately be approved for the market and used clinically only if this hurdle is overcome. The minced cartilage procedure for the treatment of focal cartilage defects recently passed this hurdle and completed the translation process. Only short-term results are currently available and early users are already using this technique although randomized studies and medium-term results are not yet available. Further studies will show whether a clinical benefit emerges and the product stays on the market.
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spelling pubmed-99723082023-02-28 Herausforderungen der Translation von innovativen Produkten und Technologien in die klinische Praxis Moser, Lukas B. Nehrer, Stefan Angele, Peter Aurich, Matthias Dyrna, Felix Hackl, Wolfgang Hess, Silvan Neubauer, Markus Niemeyer, Philipp Rupp, Marco-Christopher Zellner, Johannes Arthroskopie AGA-Research-Komitee In times of increasing technicization and digitalization, the importance of translational medicine has increased. A successful translation from basic research to the clinical application is a costly and time-consuming process that depends on many factors. Negative examples from the past (thalidomide, metal-on-metal bearings in hip arthroplasty) show that translation also entails risks for the patient. In recent years, stricter requirements for the manufacture and approval of medical devices have been introduced to ensure patient safety. Autologous chondrocyte transplantation (ACT) is an example of successful translation. Preclinical experimental animal studies were followed by clinical patient studies with market approval and implementation in the routine clinical practice. The effectiveness of a product is not the only decisive factor in whether a product is approved for the market. Between the basic science and the willingness of the market to invest in the further development and commercialization of a product is a significant hurdle, which is also called the Valley of Death. The product will ultimately be approved for the market and used clinically only if this hurdle is overcome. The minced cartilage procedure for the treatment of focal cartilage defects recently passed this hurdle and completed the translation process. Only short-term results are currently available and early users are already using this technique although randomized studies and medium-term results are not yet available. Further studies will show whether a clinical benefit emerges and the product stays on the market. Springer Medizin 2023-02-28 2023 /pmc/articles/PMC9972308/ http://dx.doi.org/10.1007/s00142-023-00593-3 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access Dieser Artikel wird unter der Creative Commons Namensnennung 4.0 International Lizenz veröffentlicht, welche die Nutzung, Vervielfältigung, Bearbeitung, Verbreitung und Wiedergabe in jeglichem Medium und Format erlaubt, sofern Sie den/die ursprünglichen Autor(en) und die Quelle ordnungsgemäß nennen, einen Link zur Creative Commons Lizenz beifügen und angeben, ob Änderungen vorgenommen wurden. Die in diesem Artikel enthaltenen Bilder und sonstiges Drittmaterial unterliegen ebenfalls der genannten Creative Commons Lizenz, sofern sich aus der Abbildungslegende nichts anderes ergibt. Sofern das betreffende Material nicht unter der genannten Creative Commons Lizenz steht und die betreffende Handlung nicht nach gesetzlichen Vorschriften erlaubt ist, ist für die oben aufgeführten Weiterverwendungen des Materials die Einwilligung des jeweiligen Rechteinhabers einzuholen. Weitere Details zur Lizenz entnehmen Sie bitte der Lizenzinformation auf http://creativecommons.org/licenses/by/4.0/deed.de (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle AGA-Research-Komitee
Moser, Lukas B.
Nehrer, Stefan
Angele, Peter
Aurich, Matthias
Dyrna, Felix
Hackl, Wolfgang
Hess, Silvan
Neubauer, Markus
Niemeyer, Philipp
Rupp, Marco-Christopher
Zellner, Johannes
Herausforderungen der Translation von innovativen Produkten und Technologien in die klinische Praxis
title Herausforderungen der Translation von innovativen Produkten und Technologien in die klinische Praxis
title_full Herausforderungen der Translation von innovativen Produkten und Technologien in die klinische Praxis
title_fullStr Herausforderungen der Translation von innovativen Produkten und Technologien in die klinische Praxis
title_full_unstemmed Herausforderungen der Translation von innovativen Produkten und Technologien in die klinische Praxis
title_short Herausforderungen der Translation von innovativen Produkten und Technologien in die klinische Praxis
title_sort herausforderungen der translation von innovativen produkten und technologien in die klinische praxis
topic AGA-Research-Komitee
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9972308/
http://dx.doi.org/10.1007/s00142-023-00593-3
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