The growth of clinical trials in Korea has been remarkable in recent years. The number of clinical trials performed by multinationals has shot up from five in 2000 to 303 in 2012, with 367 clinical trials performed by local companies. In the same year, Seoul was ranked the number one city worldwide for clinical trial competitiveness according to the US National Institute of Health, and Korea is ranked tenth worldwide. Why has Korea become such a favorable country for doing clinical trials?
Liz Chatwin, country president of AstraZeneca Korea, explains: “The clinical research facilities of institutions like Samsung Medical Center or Seoul National University are much better than anywhere else in the world, even the US. This is because they have a coordinated approach to research with all the phases of research under one roof. The implication of this is that institutions can mix expertise in pre-clinical research, translational science and clinical development in one place. They can then do clinical research very efficiently.” Chatwin also attributes a well-tailored patient database to this efficiency. “Hospital patients can be identified rapidly to fit particular criteria for a clinical trial,” she remarks. “Because the big institutions treat almost every type of patient with almost every diagnosis in their center, they can recruit individuals for just about any clinical study very quickly.”
“With 50 million citizens all covered by a single public healthcare system, Korea has a much bigger pool than other countries in term of people exposed to clinical trials,” adds Deborah Chee, president of the Korea National Enterprise for Clinical Trials (KoNECT). “The size of our economy and the characteristics of Korea’s population as the fastest-growing ageing society worldwide provide us great potential. Our disease patterns are similar to that of western countries; for the elderly, the government focuses primarily on cancer and neurodegenerative diseases.” Chee, whose goal is to increase Korea’s clinical trial positioning from tenth to fifth worldwide, notes that there are currently 15 supported regional clinical trial centers across the nation with financial support from the government and with matching funds from hospitals. Furthermore, in 2012 the government launched a program to identify new Global Centers of Excellence for Clinical Trials, of which KoNECT has selected five so far.
“These centers should further the clinical trial capability of Korea, especially focusing on specialized areas like complex clinical trials, studies in special populations, and patient-oriented Phase I clinical trials,” says Chee. “Korea is contracting more global Phase I studies for indications like oncology. So far about 160 sites have been accredited by the Ministry of Food and Drug Safety.” The explosion in number and quality of trials in Korea certainly makes an attractive case to attract multinational CROs; but to what extent do these companies actually contribute to Korean research? Jack Lee, president of Korean CRO LSK Global, notes that the recent arrival of global CROs has drasticall changed local CROs’ sponsorship base. Moreover, global CROs present in Korea have the financial muscle to hire the best Korean talent, having been trained by local CROs. “CRAs of global CROs do not complete the life cycle of studies as CRAs hop around from one CRO to next,” laments Lee. “They spend a couple years at each company and very few see a study from beginning to end. Global CROs do not contribute at all to Korean clinical drug development technology, because all the protocols, data management, statistics and project management are done at these companies’ headquarters. It is nonsensical to believe that because we are active in global clinical trials, Korea will benefit from such activities. Global CROs do not teach us anything. They just use our trained labor, stolen from companies like mine. To them, Korea is like a clinical trial assembly plant country.”
Albert Liou, Vice Chairman of Parexel Asia Pacific, takes a different tone on this issue, arguing that while “the clinical development industry in Korea has become more competitive, but also more collaborative.” “Local CROs have their own strengths, including government support and a general ‘home team advantage’, while we have different strengths and assets as a global CRO, specifically our technological capabilities.” As the local CROs have developed, Parexel has “greatly developed our role as a healthcare consultant,” explains Liou. “Often, the Korean CRO will manage trials conducted in Korea,” he says, while “Parexel provides eClinical trial technology, safety monitoring, and project management for trials conducted in other countries, and we work to together to maximize the returns from our shared clients’ resources.”
Article written by Cameron Rochette