Clinical trial design in the era of precision medicine.

🤖 Plain-English Summary

Recent rapid biotechnological breakthroughs have led to the identification of complex and unique molecular features that drive malignancies. To overcome cancer complexity, moving from drug-centric to patient-centric individualized combination therapy is critical.

🔑 Key Findings

• Precision medicine has exploited next-generation sequencing and matched targeted therapy/immunotherapy deployment to successfully transform the outlook for several fatal cancers.
• Tumor and liquid biopsy genomic profiling and transcriptomic, immunomic, and proteomic interrogation can now all be leveraged to optimize therapy.
• Multiple new trial designs, including basket and umbrella trials, master platform trials, and N-of-1 patient-centric studies, are beginning to supplant standard phase I, II, and III protocols, allowing for accelerated drug evaluation and approval and molecular-based individualized treatment.

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