Many discoveries fail in clinical studies despite promising preclinical evidence. Even though biological complexity and poorly understood disease pathology account for some of the failures, preclinical evidence often lacks the desired robustness required for successful translation. The DECIDE (Decision-Enabling Confirmation of Innovative Discoveries and Exploratory Evidence) project accompanies 12 multicenter confirmatory replication projects with the goal of developing a framework for planning, conducting, analyzing and evaluating these types of studies. With the evidence generated by the participating laboratories, the framework could support future confirmatory (multi-center) preclinical studies.

This talk will summarize the framework developed so far, with a focus on when to start and how to plan multicenter confirmatory preclinical studies, the strategies available to improve external validity and how to define key decision criteria. Furthermore, challenges and boundary conditions identified will also be discussed regarding optimization of the preclinical research pathway.