J Korean Med Assoc.  2023 Dec;66(12):716-725. 10.5124/jkma.2023.66.12.716.

Latest trends in cancer clinical trials using genomics

• Ryu H

• KMID: 2548958
• DOI: http://doi.org/10.5124/jkma.2023.66.12.716

Abstract

Background
Recent advances in molecular biology and genomics have revolutionized the understanding of the intricate molecular underpinnings of cancer. Next-generation sequencing analysis now allows identification of specific actionable genetic alterations. This breakthrough has paved the way for precision medicine in oncology, redefining the conventional clinical trial landscape and enabling personalized approaches to cancer treatment.
Current Concepts
The shift toward precision medicine involves a fundamental departure from the traditional Phases 1–4 clinical trial protocols. Instead of using uniform treatment pathways, personalized therapies are designed based on the genetic profiles of individual patients. Tumor-agnostic clinical trials are becoming as a prominent concept, encompassing innovative adaptive designs that adapt treatments to specific genetic variations. Master protocols such as umbrella studies, basket trials, platform studies, and master observational trials exemplify this transformation.
Discussion and Conclusion
International precision medicine research is characterized by exemplar studies such as the NCI-MATCH study in the United States, the Drug Rediscovery Protocol study in the Netherlands, and the Targeted Agent and Profiling Utilization Registry study in the United States. Korean oncology research also contributed to the international effort in precision medicine through initiatives like K-MASTER and the Korean Precision Medicine Networking Group, which is making commendable contributions to the global precision medicine movements.

Keyword

Next generation sequencing; Precision medicine; Cancers; Clinical trial; Genomics; 차세대염기서열분석; 정밀의학; 암; 임상시험; 유전체