CTNR Qualification Programme: Methodology of translational research - I

Tuesday, Nov 14, 2023, h 12:00 - 13:00, Zoom Link

Presenter: Prof. Dr. Marina Boccardi, Implementation Neuroscience, DZNE Rostock and UMR

Contact: marina.boccardi@uni-rostock.de

To date, the methodology of translational research is still inconsistently developed. This lesson will focus on explaining the features of the pipeline that enables new knowledge to transit from research laboratories to clinical practice.

Pharmaceutical companies follow a consolidated 4-phase development framework, to bring new knowledge to drug stores. Does the academic research context follow any such translational pipeline?

Currently, most studies labeled as “clinical” or “translational” actually use methods that are typical of basic research. While these methods are correct in a basic research context, they do not serve any translational aim. In this lesson, the students will learn wich are the basic pillars that structure any translational framework, namely, the demonstration of analytical validity, of clinical validity, and of clinical utility. They will familiarize with the distinction between assays and tests, and thus with the entirely different meaning of apparently similar studies that have the same design and outcome measures, but that actually assess the validity of assays or tests. Students will acquire the basic paramount concepts of gold standard, reference standard, and the issues influencing their choice and the validity of the studies using them. All of these concepts will provide the preliminary knowledge that will enable to grasp the meaning of entire translational frameworks, like the 4-phase framework in drug development, the 5-phase framework used in the development of Alzheimer diagnostic biomarkers, or the n-phase frameworks variably -and, again, inconsistently used- across different diagnostic fields.

Register on (Stud.IP)