Strengthening translational preclinical research through confirmatory multi-laboratory studies

Successful translation of promising preclinical findings into clinical application remains challenging. To address the rising concerns of failing clinical trials and the resulting economic, social, and ethical consequences, preclinical confirmatory studies have been proposed to generate sufficiently robust evidence for guiding the decision-making process. In a unique funding call, 17 studies in Germany aimed to confirm exploratory findings across various biomedical research fields in a rigorously planned and executed multi-laboratory set-up. Alongside these preclinical research projects, a meta-research project was funded to provide methodological support and collectively investigate confirmatory study design and experimental outcomes. After the first four-year funding period, an in-person workshop brought together representatives from the preclinical confirmatory studies to discuss lessons learned. We summarize the outcomes of these stakeholder discussions, highlight common pitfalls, and propose optimization strategies for experimental set-up and project coordination. As a result, we advocate for new roles-such as preclinical research coordinators-and improved rules and regulations in preclinical research to facilitate large-scale academic research projects. Moreover, we highlight that diverse stakeholders must collaborate to effectively integrate confirmatory multi-laboratory studies into the preclinical research ecosystem.

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Publication Details

Journal
Frontiers in Medicine
Published
2026-01-07
DOI
https://doi.org/10.3389/fmed.2025.1715361
Primary Topic
Immunotoxicology and immune responses
Type
article
Field-Weighted Citation Impact
0.00

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article

Strengthening translational preclinical research through confirmatory multi-laboratory studies

Sebastian Kühn, Juliane C. Wilcke, Iman Dalloul, Natascha Drude et al.
Frontiers in Medicine
Immunotoxicology and immune responses
article

Strengthening translational preclinical research through confirmatory multi-laboratory studies

Sebastian Kühn, Juliane C. Wilcke, Iman Dalloul, Natascha Drude, María Arroyo-Araujo, Björn Gerlach, Salbach-Hirsch Juliane, Ulf Toelch, D Bruder, Lars Björn Riecken, Sebastian Kobold, Sophia Rotter, Lena Schuler, Oliver J. Müller, Günther H. S. Richter, Pasquale Pellegrini
article en

Abstract

Successful translation of promising preclinical findings into clinical application remains challenging. To address the rising concerns of failing clinical trials and the resulting economic, social, and ethical consequences, preclinical confirmatory studies have been proposed to generate sufficiently robust evidence for guiding the decision-making process. In a unique funding call, 17 studies in Germany aimed to confirm exploratory findings across various biomedical research fields in a rigorously planned and executed multi-laboratory set-up. Alongside these preclinical research projects, a meta-research project was funded to provide methodological support and collectively investigate confirmatory study design and experimental outcomes. After the first four-year funding period, an in-person workshop brought together representatives from the preclinical confirmatory studies to discuss lessons learned. We summarize the outcomes of these stakeholder discussions, highlight common pitfalls, and propose optimization strategies for experimental set-up and project coordination. As a result, we advocate for new roles-such as preclinical research coordinators-and improved rules and regulations in preclinical research to facilitate large-scale academic research projects. Moreover, we highlight that diverse stakeholders must collaborate to effectively integrate confirmatory multi-laboratory studies into the preclinical research ecosystem.

Frontiers in MedicineVol. 12
Helmholtz Zentrum München (DE), LMU Klinikum (DE), München Klinik Schwabing (DE), Zimmer Biomet (Germany) (DE), Central Institute of Mental Health (DE), Leibniz Institute of Polymer Research (DE), University Hospital Schleswig-Holstein (DE), Helmholtz Centre for Infection Research (DE), Heidelberg Academy of Sciences and Humanities (DE), German Centre for Cardiovascular Research (DE), Leibniz Institute on Aging - Fritz Lipmann Institute (FLI) (DE), University Hospital Magdeburg (DE), Berlin Institute of Health at Charité - Universitätsmedizin Berlin (DE), University Hospital Carl Gustav Carus (DE), Charité - Universitätsmedizin Berlin (DE), Ludwig-Maximilians-Universität München (DE), University of Lübeck (DE), Otto-von-Guericke-Universität Magdeburg (DE)
Deutsche Forschungsgemeinschaft
Peace, Justice and strong institutions
Openalex Percentile: Top 95%
Immunotoxicology and immune responses
DOIOpen Access PDFOpenAlex
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