Responsible PrecliniX (RPX) – Meta-Research
Background / Rationale
Responsible PrecliniX (RPX) is a service unit of the BIH QUEST Center aiming to support researchers working on projects using preclinical models. Our goal is to improve the robustness, quality and reliability of their research findings.
At the same time, engaging with these researchers provides Responsible PrecliniX with the unique opportunity to conduct research on research (e.g. meta-research) in alignement with the theoretical framework of the QUEST Center.
Objectives
We do meta-research primarily by cooperating with lab-based researchers, with the goal of understanding the key factors for the success of a research project, so that research methodology can be continuously improved.
Methodology
From the projects we assess as part of the Responsible PrecliniX (RPX) Service Unit, we obtain information about i.e. the selection of experimental models, experimental design, and the overall implementation of responsible research practices and quality assurance measures.
In cooperation with the researchers working in the respective projects, we can address different questions, like
- How can historical data from each lab be used to refine and reduce the use of animals?
- How do newly developed models (in vivo or in vitro) compare to existing (published) ones?
- What is the status quo in a defined field regarding the use of bias-reducing measures?
- What is the status quo in a defined field regarding strategies for improvement of external validity?
Expected Results / Implications
By analyzing current practices in the planning and execution of research projects using animal models, we aim to define optimal factors for success that align with the use of responsible practices in research laboratories.
Current Projects and Collaborations
Currently, we are working on the following projects at a meta-research level, in close cooperation with the researchers responsible for the respective projects.
Current Projects and Collaborations / Accordeon
DECIDE
Responsible PrecliniX is one of the outcomes from the project DECIDE (Decision-Enabling Confirmation of Innovative Discoveries and exploratory Evidence), the accompanying project within a BMBF funding call for confirmatory multicenter preclinical studies. The project provides tailored individual consultations to the funded research groups, organizes workshops to develop new guidelines for this type of studies and assesses the results of each trial regarding the feasibility of implementing robustness-improving practices in the laboratory and regarding replication success.
Funded by the Bundesministerium für Bildung und Forschung.
C3RHeaD
The C3RHeaD is a Charité3R-funded consortium that brings experimenters and meta-researchers together to systematically evaluate and validate the potential of the Wildling mouse model as an alternative to the state-of-the-art animal models. Our role in the consortium is to ensure robust evidence generation, high scientific rigor, and harmonization of procedures. Furthermore, we will combine the evidence generated in multiple disease models regarding the efficacy of a given treatment considering a different disease onset and immune response to the treatment, compared to established models, to inform on the potential of Wildling models in improving external validity.
See here for further information.
Funded by Charité3R.
GrOwnValve
The collaboration between Responsible PrecliniX and GrownValve was funded by the BIH Clinical Incubator program. In this project, a large animal model is used to
- confirm the safety, efficacy and regulatory-compliance of a medical device previously developed by Charité researchers and
- train the surgeons that will conduct the first-in-human trial (funded independently).
Our main role will be to organize workshops with cardiovascular experts to establish the key criteria for defining the best animal model to reflect a pediatric heart condition and support physicians in planning, designing and conducting a preclinical trial, ensuring high-quality data collection, including harmonization of protocols and procedures as well as analyses strategies.
Further Information and Links
- Carneiro, C.F.D., Drude, N.I., Hülsemann, M., et al. Mapping strategies towards improved external validity in preclinical translational research. Exp. Opinion Drug Disc. (2023)
- Drude, N.I., Martinez-Gamboa, L., Danziger, M. et al. Planning preclinical confirmatory multicenter trials to strengthen translation from basic to clinical research – a multi-stakeholder workshop report. Transl Med Commun 7, 24 (2022)
- Carneiro, C.F.D., Amorim, F.E., Amaral, O.B. A meta-analysis of the effect of protein synthesis inhibitors on rodent fear conditioning. bioRxiv [preprint] (2022)
- Hülsemann, M., Wiebach, J., Drude, N.I. et al. Introducing quality measures in an academic research consortium. EMBO Reports (2022)23:e55095
- Drude, N.I., Martinez-Gamboa, L., Danziger, M. et al. Science Forum: Improving preclinical studies through replications. eLife 10:e62101
- Kurreck, C., Castaños-Velez, E., Freyer, D. et al. Improving quality of preclinical academic research through auditing: A feasibility study. PLoS ONE (2020) 15(10): e0240719
- Dirnagl, U., Kurreck, C., Castaños-Velez, E., et al. Quality management for academic laboratories: burden or boon? EMBO Reports (2018) 19:e47143
- Carneiro, C.F.D., Moulin, T.C., Macleod, M.R., et al. Effect size and statistical power in the rodent fear conditioning literature – A systematic review. PLoS ONE (2018) 13(4): e0196258
- Dirnagl, U., Przesdzing, I., Kurreck, C. et al. A Laboratory Critical Incident and Error Reporting System for Experimental Biomedicine. PLoS Biol (2016) 14(12): e2000705
Funder and Cooperation Partners
Project funding
Institutional initiative from the BIH QUEST Center for Responsible Research
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