The rising presence of clinical trials (CT) in the Asia-Pacific region is predominantly driven by the East Asian region which includes China, Japan, Korea, Taiwan and Hong Kong. Over the past decade, Korea has become a global clinical trial hub and is one of the leading clinical trial destinations in the Asian region; with approximately 80% of its CT being multinational trials from 2001-2012.
The support of entities such as Korea National Enterprise for Clinical Trials (KoNECT), which was established by the Korean government, has increased CT infrastructure development and advancement by promoting the country’s clinical trial capabilities to the world.
In 2012, the Korean government approved 303 multinational studies and 367 domestic trials. Furthermore, data collected from clinicaltrials.gov indicates that Korea listed 380 active studies over the last five years – 53 in Phase I, 120 in Phase II and 207 in Phase III. Global and local CT have burgeoned in South Korea over the past decade. For example, based on the number of CT sites per city, Seoul is among the top 10 cities worldwide.
In the past, a large part of clinical trial activity in Korea were domestic trials, sponsored by local pharmaceutical or biotechnology companies. Consequently, the contract research market has developed with many local contract research organization (CRO) players. As Korea steps up its involvement in global CTs, the Korean government has invested heavily in improving the quality of its infrastructure, services and resources.
To encourage excellent infrastructure in Korea, KoNECT is currently developing an optional accreditation program for local CROs. In addition, KoNECT organizes various clinical audits of Korean CROs and sites to ensure international standards are maintained. KoNECT has also been involved in activities which include customized information and business matching services to facilitate the smooth planning and conduct of CTs in Korea.
As of August 2015, the Korean Ministry of Food and Drug Safety (MFDS) has inspected and certified over 170 clinical trial sites, placing Korea second globally for number of CT sites. Korean investigators are trained to meet the highest standards of the international medical community, meeting regulatory standards and GCP compliance. Investigators are also supported by teams of professionals including well-trained clinical research coordinators who ensure every aspect of the study conduct is fulfilled.
To maintain the high quality CT services Korea provides, the Korean MFDS is introducing a mandatory 40 hour training program for new clinical research associates (CRA) which will be followed by 8 hr p.a. of training. As the role of the CRA is to monitor sites for protocol and good clinical practice (GCP) compliance; this training is expected to improve data quality even more.
With support from the Korean government, Korea has developed a sophisticated health system. An implementation of rigorous training programs have resulted in world-class clinical expertise and experience and an outstanding specialization in specific disease areas and familiarity with international gold-standard protocols. As a result of this and the collaborative efforts of the MFDS, KoNECT, institutions and industry, there has been a steady influx of multinational trials seeking reliable and cost-effective trial sites. Moreover, Korea has cultivated a reputation for CT professionalism; personnel in Korea are recognized for their accountability and strong sense of responsibility in comparison to other countries. Strategies to maintain this high reputation include supporting investigators with further training modules, such as advanced GCP training modules.
With a healthcare market size of approximately US $17 billion, Korea is an attractive healthcare market for global and local pharmaceutical and biotechnology companies. It already possesses high quality, westernized-style medical and scientific infrastructure for clinical research. With various government support structures to encourage global clinical trial activity in Korea, such as the independent accreditation process discussed, Korea’s appeal as a destination for CTs on the global stage is very likely to increase.