Im Seock-Ah, Lee Dae-Won, Kang Ryungwoo, Kim Jee Hyun, Kim Dong-Wan, Jang In-Jin, Lee Jong-Seok, Bang Yung-Jue
Department of Internal Medicine, Clinical Trials Center, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.
Korea National Enterprise for Clinical Trials, Seoul, Korea.
Chin Clin Oncol. 2019 Jun;8(3):27. doi: 10.21037/cco.2019.06.05.
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.
韩国已成为全球临床试验的中心。韩国《良好临床实践规范》于1995年立法，并于2001年进行修订以采用国际协调会议（ICH）的《良好临床实践规范》（GCP）。2002年引入了新的临床试验授权（CTA）流程，以简化监管流程并加快研究启动速度，促进了韩国的临床试验注册。2002年之后，在韩国进行的跨国试验数量开始迅速增加。最初集中在后期试验，但随后转向早期研究，包括转化研究以及药代动力学（PK）和药效学（PD）研究，包括种族差异研究。在全球范围内，首尔国立大学医院临床试验中心（SNUH CTC）是经验最丰富的临床研究机构之一。2018年，SNUH CTC肿瘤学团队启动了33项III期研究、43项II期研究和44项I期研究。2018年，肿瘤学I期临床试验占SNUH CTC新启动I期临床试验的42.7%。我们肿瘤学团队最重要的优势之一是，SNUH和首尔国立大学盆唐医院临床试验中心（SNUBH CTC）在一个团队中共同致力于所有实体瘤类型的研究。这种合作工作在早期试验（包括篮子试验、伞式试验和平台试验）中招募多队列患者方面非常高效。SNUH肿瘤学团队的主要重点之一是进行人体首次I期研究。我们相信通过转化研究进行靶点识别和富集是药物开发中的一个重要过程。SNUH/SNUBH CTC将继续为全球药物开发开展一流的临床试验。
