Fig. 1
From: New clinical trial design in precision medicine: discovery, development and direction
The biological logic of new biomarker-guided clinical trial design in precision medicine. The essence of precision medicine is to explore the unknown relationship between drugs, targets, and diseases in the human body. The left and right arms represent the drugs and diseases, respectively. The circles distributed throughout the lungs and body represent the therapeutic targets. The world of precision medicine in human body is an undeveloped ocean, containing extensive therapeutic targets represented by colorful circles based on next-generation sequencing and other biological technologies. The diseases such as lung cancer are classified into different subtypes based on different therapeutic targets. The molecular subtype-guided therapy in a certain disease is the biological logic of umbrella trial design. A certain target may appear in the lungs and other parts of the body with similar biological characteristics. Based on the successful treatment experience of lung cancer, exploring the therapeutic potential of a certain target for the disease of other body parts is the underlying logic of the basket trial design. The dynamic concept conveyed by the diffuse distribution of circles in the ocean is the core of platform trial design. The biomarker-guided ship of precision medicine clinical trial design is constantly advancing, riding the wind and waves in the undeveloped ocean of precision medicine
