Article
Clinical Development in the Precision Medicine Era
Precision medicine is fundamentally reshaping clinical development by shifting from broad, one-size-fits-all approaches to biomarker-driven, patient-specific strategies that improve outcomes and efficiency. In oncology especially, advances in genomics, liquid biopsy, and AI-enabled trial design are enabling targeted therapies tailored to tumor biology, while innovative trial models (e.g., basket, enrichment, adaptive cohorts) dramatically accelerate timelines—potentially reducing development from ~10 years to as little as 2.5–3 years. This shift requires new operating models: tighter patient segmentation, more complex trial design, integration of real-world data, and specialized site capabilities. Increasingly, success is less about the molecule alone and more about orchestrating the entir
