To promote the translation from preclinical findings into clinical contexts, BIH has established a comprehensive translational research and development environment.
For this translation to be successful, the robustness of preclinical studies is pivotal. Responsible PrecliniX will extend the existing ecosystem and form a hub connecting multiple stakeholders in preclinical research like BIH Core Facilities to bring together complementing expertise and to ensure and provide guidance towards robust evidence and clinical translation. In this context, robustness refers to two key components in quantitative research, reliability (consistency in measurement) and validity (measure reflects actual theoretical pathomechanism).
In tight cooperation with core facilities, constant exchange with the Clinical Study Center, and regulatory affairs representatives, Responsible PrecliniX will assess and improve preclinical research to generate patient-informed and robust evidence, ensure high research standards, clinical relevance, and consequently iterative translation, i.e., from bench to bed and back.
Scientists can approach us early on at the stage of proposal writing and Responsible PrecliniX accompanies projects from the basic idea to translation through a series of Go/No Go decision points. Responsible PrecliniX offers support concerning the model (including potential alternatives), statistics (sample size calculation), experimental design, robustness, and the role or need of replication studies (within a laboratory or between laboratories).
Next to counseling and supporting individual researchers and research groups, Responsible PrecliniX will meta-analytically (self)assess projects and their evaluation. Based on continuous communication with scientists and collaborators, we develop a metric to estimate the robustness of a project and map its likelihood of translational success. To assess and refine this metric, we will monitor and evaluate the (long) period between a preclinical discovery and the actual clinical application (or No-Go decision point). The joint efforts will yield a guide toward best practices in translational preclinical research.