Strengthening translational preclinical research through confirmatory multi-laboratory studies

Publikation: Beitrag in Fachzeitschrift › Forschungsartikel › Beigetragen › Begutachtung

Beitragende

  • Sophia C. Rotter - , Berliner Institut für Gesundheitsforschung in der Charité (Autor:in)
  • María Arroyo-Araujo - , Berliner Institut für Gesundheitsforschung in der Charité (Autor:in)
  • Natascha I. Drude - , Berliner Institut für Gesundheitsforschung in der Charité (Autor:in)
  • Pasquale Pellegrini - , Berliner Institut für Gesundheitsforschung in der Charité (Autor:in)
  • Sebastian Kobold - , Ludwig-Maximilians-Universität München (LMU), Helmholtz Zentrum München - Deutsches Forschungszentrum für Gesundheit und Umwelt (Autor:in)
  • Günther H.S. Richter - , Charité – Universitätsmedizin Berlin (Autor:in)
  • Oliver J. Müller - , Universitätsklinikum Schleswig-Holstein Campus Kiel, Deutsches Zentrum für Herz-Kreislaufforschung (DZHK) (Autor:in)
  • Dunja Bruder - , Otto-von-Guericke-Universität Magdeburg, Helmholtz-Zentrum für Infektionsforschung (HZI) (Autor:in)
  • Lars B. Riecken - , Leibniz-Institut für Alternsforschung – Fritz-Lipmann-Institut (Autor:in)
  • Björn Gerlach - , Zentralinstitut für Seelische Gesundheit (ZI), Guarantors of EQIPD e.V., PAASP GmbH (Autor:in)
  • Lena Schuler - , Technische Universität München (Autor:in)
  • Juliane Salbach-Hirsch - , Medizinische Klinik und Poliklinik III (Autor:in)
  • Iman Dalloul - , Ludwig-Maximilians-Universität München (LMU) (Autor:in)
  • Sebastian Kühn - , Leibniz-Institut für Polymerforschung Dresden (Autor:in)
  • Juliane C. Wilcke - , Ludwig-Maximilians-Universität München (LMU) (Autor:in)
  • Ulf Toelch - , Berliner Institut für Gesundheitsforschung in der Charité (Autor:in)

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.

Details

OriginalspracheEnglisch
Aufsatznummer1715361
FachzeitschriftFrontiers in medicine
Jahrgang12
PublikationsstatusVeröffentlicht - 2025
Peer-Review-StatusJa

Externe IDs

ORCID /0000-0001-7097-9953/work/224858712
PubMed 41574368

Schlagworte

ASJC Scopus Sachgebiete

  • Allgemeine Medizin - confirmatory studies, experimental design, multi-laboratory trials, preclinical research, reproducibility, stakeholder engagement

Schlagwörter

  • confirmatory studies, experimental design, multi-laboratory trials, preclinical research, reproducibility, stakeholder engagement