Strengthening translational preclinical research through confirmatory multi-laboratory studies

Area of Science:

• Biomedical Research
• Translational Science
• Meta-Research

Background:

• Translating preclinical findings into clinical applications is challenging, leading to high failure rates in clinical trials.
• Economic, social, and ethical consequences necessitate more robust evidence from preclinical studies.
• Preclinical confirmatory studies are proposed to generate reliable evidence for decision-making.

Purpose of the Study:

• To confirm exploratory findings across diverse biomedical fields using a multi-laboratory approach.
• To provide methodological support and investigate confirmatory study designs and outcomes.
• To identify lessons learned, common pitfalls, and optimization strategies for preclinical research.

Main Methods:

• A unique funding call supported 17 German preclinical confirmatory studies.
• A meta-research project offered methodological guidance and analyzed study outcomes.
• Stakeholder discussions and workshops synthesized experiences from the first funding period.

Main Results:

• Common pitfalls in experimental set-up and project coordination were identified.
• Strategies for optimizing large-scale academic research projects were proposed.
• The need for new roles, like preclinical research coordinators, was emphasized.

Conclusions:

• Improved rules and regulations are needed to facilitate large-scale preclinical research.
• Collaboration among diverse stakeholders is crucial for integrating confirmatory studies.
• Enhancing preclinical research infrastructure can improve the translation of findings to clinical practice.