Challenges and insights of early oncology drug development in the Asia-Pacific region: introduction of phase I oncology clinical trial center and experience sharing for early clinical trials in Seoul National University Hospital, Korea.

Korea has become the hub of clinical trials in the world. Korea Good Clinical Practice was legislated in 1995, with an amendment in 2001 to adopt International Council of Harmonization (ICH)-Good Clinical Practive (GCP). New Clinical Trial Authorization (CTA) process, which was introduced in 2002 to streamline the regulatory process along with faster study start up, facilitated clinical trials registration in Korea. Following 2002, the number of multinational trials conducted in Korea began to increase rapidly. It was initially centered on late-phase trials, but subsequently moved on to early phase research incorporating translational research and pharmacokinetic (PK) and pharmacodynamic (PD) studies including ethnic difference research. Globally, Seoul National University Hospital Clinical Trials Center (SNUH CTC) is one of the most experienced clinical research facilities. In 2018, 33 phase III studies, 43 phase II studies, and 44 phase I studies were initiated at SNUH CTC oncology team. Oncology phase I clinical trials contributed 42.7% of newly started phase I clinical trials in SNUH CTC in 2018. One of the most important strengths of our oncology team is that SNUH and Seoul National University Bundang Hospital Clinical Trials Center (SNUBH CTC) are working together in one team for all solid tumor types. This collaborative work was very efficient to recruit patients for multi-cohort in early phase trials including basket trial, umbrella trial, and platform trials. One of the main focus of SNUH oncology team is to perform first in human phase I study. We believe target identification and enrichment through translational research is an important process in drug development. SNUH/SNUBH CTC will continue top-notch clinical trials for the global drug development.