Paradigm Shift in Clinical Trial Design
Biomarker-based therapy is the key to personalized medicine
Conventional Trial Design : Low response rates in each indication
- Patients of
specific cancer indication - Drug to treat
specific cancer indication - Low treatment
responses observed
New Trial Design Paradigm : Biomarker-based Precision Medicine
- Gene expression level, gene mutation, and protein analysis regardless of cancer type
- Biomarker based
personalized treatment - High response rates
by personalized therapy
Adaptive trial design maximizes the value of anticancer drugs
Traditional Clinical Trials : Fixed Model
Biomarker-positive Biomarker-negative patients enrolled → Higher trial costs, longer development time / Lower probability of trial success
Adaptive (‘Seamless’) Clinical Trials : Flexible Model
Only biomarker-positive patients enrolled → Statistical validation with small number of patients, Preliminary clinical data can be used for NDA/BLA approvals