This article was also published on PharmaPhorum
South Korea, a country in Northeast Asia with a population of 49 million, has become a global clinical trial hub over the past decade. The Korean government has offered a variety of incentives to support the country’s biotechnology and clinical trial industries. Due to the many advantages of running clinical trials in Korea, numerous multinational clinical research organizations (CROs) — and pharmaceutical and medical device companies — have initiated trials and partnerships in Korea over the past decade.
Korea’s pharmaceutical market will be valued at close to $20 billion by 2015. The medical device market in Korea was worth about $3.5 billion in 2013. Healthcare and medical research in Korea are quickly approaching the quality standards found in the West and Japan. Furthermore, the country offers a prime geographical base for the Northeast Asian markets. Thus, Korea is a high-quality and cost effective option for clinical trial research in Asia.
A local presence is required for successful clinical trials in Korea. This can be in the form of an in-country office, a CRO or a regulatory consultant with local expertise. In-country knowledge of issues like site identification, hospital(s) or research centers that can run your trials, types of studies possible, timelines, accessible patient pools, and available infrastructure will all be key for successful Korean clinical trials.
Korea has one of the fastest study start-up times in Asia, with well-defined regulatory and review processes. The Korean Ministry of Food and Drug Safety (MFDS) is the main regulatory body for drugs, medical devices, food and cosmetic products. Clinical trials must be conducted in accordance with Korean Good Clinical Practice, implemented in 1995 and later revised in 2001 to be in line with the ICH guidelines.
To conduct a clinical trial in Korea, the sponsor must obtain institutional review board (IRB) approval. The MFDS provides pre-investigational new drug consultation services. The sponsor should submit a clinical trial application with the appropriate supporting documents, all of which should be translated into Korean. The IRB approval process can take 1-2 months in Korea.
KOREA GOVERNMENT SUPPORT AND OTHER ADVANTAGES
The Korean government has promoted biotechnology since the 1980s. One key component of this support is strengthening industrial capacity — including clinical trials. The government has advocated Korea as the premier clinical trial location in Northeast Asia for almost a decade.
The government provides significant support to the clinical trial industry, such as grants for trial centers to build infrastructure and facilitate multi-site trials, tax breaks for R&D costs and increased training for investigators and clinical researchers.
The Korea National Enterprise for Clinical Trials was established by the government in 2007 to advance standards, promote training and collaboration, forge industry partnerships and build an advanced clinical trial infrastructure. In 2011, the Korea Drug Development Fund was launched with a budget of $1 billion to help transform Korea into a global leader for the development of new drugs.
Streamlined regulations have led to a growing number of clinical trials in Korea, which is ranked among the top 15 countries globally for the highest number of clinical trials. Based on the number of clinical trial sites per city, Seoul is among the top 10 cities worldwide. In 2012, the government approved 303 multinational studies and 367 domestic trials. ClinicalTrials.gov currently lists 428 active studies, with another 1,587 in the recruiting or pre-recruiting phases.
Korea offers a high-quality, Western-style medical and scientific infrastructure for clinical research. Most trials are undertaken at Korea’s leading hospitals with state-of-the-art facilities. These hospitals are both highly professional and efficient in conducting and supporting trials. English proficiency is widespread, and many trial documents are written in English. Korea also has highly ranked biotech research institutes and high-tech medical clusters. The government has supported the construction of a network of Clinical Trial Centers at 15 major regional medical centers across Korea and more than 164 investigational trial cites nationwide.
The patient population in Korea also offers benefits for multinational clinical trials. The population of 49 million is increasingly westernized. This has led to a large rise in incidence rates of Western diseases — like cancer, diabetes, cardiovascular diseases, obesity and age-related illnesses. The country’s nearly 100% literacy rate simplifies the informed consent process, as does the single language translation requirement. Culturally, doctors and patients have a strong relationship — which helps with patient enrollment, retention and compliance during trials.
Oncology trials account for approximately one-third of the global trials conducted in Korea. Cardiovascular and anti-infective trials are also common. Korea is also ranked in the top 5 globally for stem cell research clinics.
WESTERN COMPANIES OPERATING IN THE KOREAN CLINICAL TRIAL SECTOR
Almost all major international CROs and pharmaceutical companies are present in Korea as trial operators or sponsors. Korea National Enterprise for Clinical Trials (KoNECT) has established partnerships with multinational CROs – such as Quintiles and ICON — to improve clinical research standards, infrastructure, researcher expertise and trial capacity. Quintiles has been operating in South Korea since 2000, and the company says that their Korean office is one of their biggest in East Asia. ICON has been active in Korea since 2005 and is managing almost 100 protocols in Korea.
The Korea Drug Development Fund (KDDF) has also established partnerships with multinational CROs, like WCCT Global, PAREXEL and Novotech. In June 2014, Celerion (Lincoln, Nebraska) and the KDDF signed a memorandum of understanding giving KDDF funded companies access to Celerion’s expertise in early clinical research, bioanalysis and external partnerships. Celerion’s President and CEO said that Korea would be a world leader in biomedical research and development by 2020.
The Korean government is continuing to invest heavily in drug development. In July 2014, President Park Geun-Hye announced a series of government plans to build the biotechnology industry, including expanding the use of advanced stem cell research facilities, training additional biotech industry researchers and increasing the number of diseases that can be researched.
Korea has shown a long-term commitment to becoming one of the top clinical trial destinations in the world. The country offers benefits like advanced infrastructure and facilities, expert researchers, a streamlined regulatory structure and Westernized patient population. Given Korea’s many advantages for conducting trials, multinational pharmaceutical companies, medical device companies and CROs organizing clinical trials in Asia would be well advised to consider establishing trial sites in Korea.