Towards better preclinical research: Key takeaways from confirmatory multi-laboratory trials and stakeholder discussions

Successful translation of promising preclinical findings into clinical applications remains challenging. To address the rising concerns of failing clinical trials and the resulting economic, social, and ethical burdens, preclinical confirmatory studies have been proposed to generate sufficiently robust evidence for guiding the decision-making process. Seventeen federally funded confirmatory trials in Germany were assigned to validate exploratory findings across various biomedical research fields in a rigorously planned and executed multi-laboratory set-up. Under the same funding call, the scientific accompanying module DECIDE (Decision-Enabling Confirmation of Innovative Discoveries and exploratory Evidence) provided methodological support and conducted meta-research on the design and outcome of the confirmatory projects. After the first four-year funding period, DECIDE facilitated an in-person workshop bringing together representatives from the confirmatory trials to discuss lessons learned. We summarize the outcomes of these stakeholder discussions, highlighting common pitfalls and proposing solution strategies in the experimental set-up and project coordination. As a result, we advocate for new roles – such as preclinical research coordinators – and better rules in preclinical research to facilitate large-scale academic research projects. Moreover, to effectively integrate confirmatory multi-laboratory studies into the preclinical research ecosystem, diverse stakeholders must collaborate to support robust evidence synthesis.