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Recommendations for robust and reproducible preclinical research in personalised medicine
BACKGROUND: Personalised medicine is a medical model that aims to provide tailor-made prevention and treatment strategies for defined groups of individuals. The concept brings new challenges to the translational step, both in clinical relevance and validity of models. We have developed a set of reco...
Autores principales: | , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9826728/ https://www.ncbi.nlm.nih.gov/pubmed/36617553 http://dx.doi.org/10.1186/s12916-022-02719-0 |
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author | Fosse, Vibeke Oldoni, Emanuela Bietrix, Florence Budillon, Alfredo Daskalopoulos, Evangelos P. Fratelli, Maddalena Gerlach, Björn Groenen, Peter M. A. Hölter, Sabine M. Menon, Julia M. L. Mobasheri, Ali Osborne, Nikki Ritskes-Hoitinga, Merel Ryll, Bettina Schmitt, Elmar Ussi, Anton Andreu, Antonio L. McCormack, Emmet |
author_facet | Fosse, Vibeke Oldoni, Emanuela Bietrix, Florence Budillon, Alfredo Daskalopoulos, Evangelos P. Fratelli, Maddalena Gerlach, Björn Groenen, Peter M. A. Hölter, Sabine M. Menon, Julia M. L. Mobasheri, Ali Osborne, Nikki Ritskes-Hoitinga, Merel Ryll, Bettina Schmitt, Elmar Ussi, Anton Andreu, Antonio L. McCormack, Emmet |
author_sort | Fosse, Vibeke |
collection | PubMed |
description | BACKGROUND: Personalised medicine is a medical model that aims to provide tailor-made prevention and treatment strategies for defined groups of individuals. The concept brings new challenges to the translational step, both in clinical relevance and validity of models. We have developed a set of recommendations aimed at improving the robustness of preclinical methods in translational research for personalised medicine. METHODS: These recommendations have been developed following four main steps: (1) a scoping review of the literature with a gap analysis, (2) working sessions with a wide range of experts in the field, (3) a consensus workshop, and (4) preparation of the final set of recommendations. RESULTS: Despite the progress in developing innovative and complex preclinical model systems, to date there are fundamental deficits in translational methods that prevent the further development of personalised medicine. The literature review highlighted five main gaps, relating to the relevance of experimental models, quality assessment practices, reporting, regulation, and a gap between preclinical and clinical research. We identified five points of focus for the recommendations, based on the consensus reached during the consultation meetings: (1) clinically relevant translational research, (2) robust model development, (3) transparency and education, (4) revised regulation, and (5) interaction with clinical research and patient engagement. Here, we present a set of 15 recommendations aimed at improving the robustness of preclinical methods in translational research for personalised medicine. CONCLUSIONS: Appropriate preclinical models should be an integral contributor to interventional clinical trial success rates, and predictive translational models are a fundamental requirement to realise the dream of personalised medicine. The implementation of these guidelines is ambitious, and it is only through the active involvement of all relevant stakeholders in this field that we will be able to make an impact and effectuate a change which will facilitate improved translation of personalised medicine in the future. |
format | Online Article Text |
id | pubmed-9826728 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-98267282023-01-09 Recommendations for robust and reproducible preclinical research in personalised medicine Fosse, Vibeke Oldoni, Emanuela Bietrix, Florence Budillon, Alfredo Daskalopoulos, Evangelos P. Fratelli, Maddalena Gerlach, Björn Groenen, Peter M. A. Hölter, Sabine M. Menon, Julia M. L. Mobasheri, Ali Osborne, Nikki Ritskes-Hoitinga, Merel Ryll, Bettina Schmitt, Elmar Ussi, Anton Andreu, Antonio L. McCormack, Emmet BMC Med Guideline BACKGROUND: Personalised medicine is a medical model that aims to provide tailor-made prevention and treatment strategies for defined groups of individuals. The concept brings new challenges to the translational step, both in clinical relevance and validity of models. We have developed a set of recommendations aimed at improving the robustness of preclinical methods in translational research for personalised medicine. METHODS: These recommendations have been developed following four main steps: (1) a scoping review of the literature with a gap analysis, (2) working sessions with a wide range of experts in the field, (3) a consensus workshop, and (4) preparation of the final set of recommendations. RESULTS: Despite the progress in developing innovative and complex preclinical model systems, to date there are fundamental deficits in translational methods that prevent the further development of personalised medicine. The literature review highlighted five main gaps, relating to the relevance of experimental models, quality assessment practices, reporting, regulation, and a gap between preclinical and clinical research. We identified five points of focus for the recommendations, based on the consensus reached during the consultation meetings: (1) clinically relevant translational research, (2) robust model development, (3) transparency and education, (4) revised regulation, and (5) interaction with clinical research and patient engagement. Here, we present a set of 15 recommendations aimed at improving the robustness of preclinical methods in translational research for personalised medicine. CONCLUSIONS: Appropriate preclinical models should be an integral contributor to interventional clinical trial success rates, and predictive translational models are a fundamental requirement to realise the dream of personalised medicine. The implementation of these guidelines is ambitious, and it is only through the active involvement of all relevant stakeholders in this field that we will be able to make an impact and effectuate a change which will facilitate improved translation of personalised medicine in the future. BioMed Central 2023-01-08 /pmc/articles/PMC9826728/ /pubmed/36617553 http://dx.doi.org/10.1186/s12916-022-02719-0 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Guideline Fosse, Vibeke Oldoni, Emanuela Bietrix, Florence Budillon, Alfredo Daskalopoulos, Evangelos P. Fratelli, Maddalena Gerlach, Björn Groenen, Peter M. A. Hölter, Sabine M. Menon, Julia M. L. Mobasheri, Ali Osborne, Nikki Ritskes-Hoitinga, Merel Ryll, Bettina Schmitt, Elmar Ussi, Anton Andreu, Antonio L. McCormack, Emmet Recommendations for robust and reproducible preclinical research in personalised medicine |
title | Recommendations for robust and reproducible preclinical research in personalised medicine |
title_full | Recommendations for robust and reproducible preclinical research in personalised medicine |
title_fullStr | Recommendations for robust and reproducible preclinical research in personalised medicine |
title_full_unstemmed | Recommendations for robust and reproducible preclinical research in personalised medicine |
title_short | Recommendations for robust and reproducible preclinical research in personalised medicine |
title_sort | recommendations for robust and reproducible preclinical research in personalised medicine |
topic | Guideline |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9826728/ https://www.ncbi.nlm.nih.gov/pubmed/36617553 http://dx.doi.org/10.1186/s12916-022-02719-0 |
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