Figure 7.

The iterative circle of refined clinical translation.

(A) Insufficient performance with conventional approaches mandates adjustments to yield faster and more efficient access to novel therapies, including: (1) better use of open data and advanced bioinformatics, (2) improved trials design with iterative adjustments, and (3) advancements in biomedical engineering to improve product properties and clinical delivery. (B) Measures to support better use of open data and advanced bioinformatics, such as SysBio and AI approaches. (C) Measures for improved clinical trial design, including stronger focus on secondary endpoints and exploratory biomarkers to support iterative adjustments in clinical trials design and treatment concepts for qualified restratification of patients according to therapy responder (green) and non-responder (red) status and improved survival.