Korean clinical trials: its current status, future prospects, and enabling environment

Abstract

115 Vol. 27, No.4, Dec 30, 2019 Copyright © 2019 Dong Hyun Chee It is identical to the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/). This paper meets the requirement of KS X ISO 9706, ISO 9706-1994 and ANSI/NISO Z.39.48-1992 (Permanence of Paper). History of Korean clinical trials Clinical trials provide information and important evidence to regulators, physicians, payors, and patients that support decision-making in improving access to better medicines with a meaningful impact on patients. Over the past two decades, Korean clinical trials have demonstrated unprecedented growth. Regulatory reform, including the adoption of ICH-GCP in 2000 and the introduction of clinical trial authorization in 2002, have led to these changes together with the government’s continuous investment in clinical trial capacity building since 2004 such as the “Regional Clinical Trial Center” and “Global Center of Excellence” programs through the Korea National Enterprise for Clinical Trials (KoNECT). KoNECT has analyzed every year the ClinicalTrials.gov data downloaded from the website, which has the biggest coverage of clinical trials registered by industry sponsors in the world among all primary clinical trial registries for the numbers and shares of the protocols and sites of global industry-sponsored clinical trials in top 30 countries. It also analyzes the Ministry of Food and Drug Safety (MFDS) clinical trial authorization data that are open to public on their website for the trend of clinical trials conducted in Korea. In 2000, the number of clinical trials approved by the MFDS was only 33, including 5 multinational studies. However, this number increased to 679 in 2018, with 289 multinational studies.[1] Seoul became the world s top city in terms of the number of clinical trials in 2012, and Korea has ranked amongst the top 10 countries that have conducted clinical trials since 2010, according to the analysis of ClinicalTrials. gov by KoNECT.[2] This has led to the question of what were the drivers of the growth in Korean clinical trials? To answer this question, both domestic and multinational clinical trials have contributed to the growth of Korean clinical trials. Among these, multinational Phase 3 studies and domestic phase 1 studies have largely been increased. Indeed, there was a leap in the number of phase 1 studies by domestic companies in 2011 from 75 to 130, with an increase of 73.3% from the previous year.[3] Among the 130 domestic phase 1 studies, around 40% of the phase 1 studies were for new drugs developed by domestic companies, whereas approximately 50% of them were for fixed combination drugs, new formulations of marketed drugs, and others.[4] In 2018, the number of phase 1 trials approved by the MFDS reached 211, which represented an increase of 19.9% from 2017. Among these 211 phase 1 trials, 161 (76.3%) were considered domestic, whereas only 39 were related to new molecular entities, including 37 studies by domestic companies. In the same year, 188 industry-sponsored phase 3 trials were approved by MFDS, and among them, only thirty-one studies were filed by domestic companies.[5] Based on the ClinicalTrials.gov data analysis, the total number of registered industry-sponsored phase 2 and phase 3 studies in 2018 was around 1.4 times and 2.5 times that of phase 1 studies, respectively.[2] However, the ratio of industry-sponsored domestic phase 1 : phase 2 : phase 3 was 6.7 : 1.0 : 1.3 based on the analysis of MFDS data.[5] A majority of the multinational studies conducted in Korea are funded by foreign sponsors. In 2018,[2] Korea was ranked 11 in its share of global multinational trials, suggesting that Korean companies primarily conduct domestic studies, whereas multinational and multisite studies are conducted in Korea as part of a global development program by global or foreign sponsors. With reference to therapeutic areas, oncology is the strongest area related to clinical trials in Korea. The number of MFDSapproved oncology studies across domestic and multinational studies was 247 (36.4%) in 2018.[1] Among these, studies inReviewer This article was invited and reviewed by the editors of TCP. Korean clinical trials: its current status, future prospects, and enabling environment