Strong Government Support and Commitment
Favorable Regulatory and Ethics Committee Review Process
High Patient Access and Fast Patient Recruitment
CTCs with World-class Facilities and Research Network
Excellence in Quality in Early and Late Phase Clinical Trials
Highly educated and motivated medical staff
Facilitation of East-Asian clinical development
Geographic Advantages & Cutting-Edge IT Infrastructure
The Korean Ministry Of Health and Welfare(MOHW) has strategically invested in clinical trials infrastructure development and advancement since as early as 2004.
The Korea National Enterprise for Clinical Trials(KoNECT) was established in 2007 funded by MOHW to promote the country's clinical trials capabilities and to actively develop clinical trials infrastructure through the establishment of 15 regional clinical trials centers, training and certification of clinical trials professionals, and support for R&D of new clinical trials technologies.
In April 2015, KoNECT was transformed into a non-profit foundation, sponsored funded by MOHW, to continue advancing clinical trials infrastructure and supporting clinical trials in Korea.
Korean sites are renowned for having among the fastest study start-up times, with well-defined regulatory and review processes.
The Korean government has been streamlining the regulatory process, continuously harmonizing with the global standards.
Significant regulatory reform process include the implementation of GCP guideline as early as in as early as 1995, the separation and introduction of IND from NDA in 2002, alleviating the longer IND approval timeline to 30 days and enabling participation in multi-regional clinical trials.(MRCT)
|1995||KFDA implemented GCP guidelines(KGCP) and became 2nd country in implementing GCP in Asia Effective from October 1.1995|
|2000||Adoption of ES bridging study: KFDA adopted bridging concept in reviewing data of the foreign developed new drugs for marketing approval in Korea|
|2001||KGCP was revised to be equivalent to ICH-GCP|
|2002||Separation and introduction of IND from NDA system alleviated the longer IND approval timelines to 30 days|
|2004||Establishment of 15 RCTC(Regional Clinical Trials Centre) that co-ordinates and reviews the infrastructure if the hospitals and academic institutes conducting clinical trials meet the international quality standards|
|2007||Establishment of KoNECT by Korea Ministry of Health and Welfare|
|2008||KAIRB(Korean Association of IRBs) was established to organize IRB education. enhance review capacities and faster IRB networking|
MFDS’s efforts for regulatory reforms are ongoing; e.g. 14 day review for healthy volunteer studies(vs. previously 30 days), accept clinical protocols in English for phase 1 study. The IRB approval process typically occurs in parallel to MFDS review, with busy sites holding IRB meetings on a weekly basis.
Korea’s public healthcare system ensures reimbursement for most medical expenses, so that almost 97% of 51 million Korean population have healthcare coverage by national insurance system.
Major university hospitals are generally larger than 1,000 beds and see as many as 10,000 or more outpatients a day. Affiliated with university hospitals, CTCs have high volume of patient pool and are able to make fast patient recruitment. Accordingly, Korean CTCs are well recognized as one of the most rapid patient recruitment site with relatively low and insignificant drop-out rate for the conduct of clinical trials.
There are currently 22 clinical trials centers(CTCs) in Korea, all of which are affiliated to university hospitals. CTCs are to provide the world-class facilities and infrastructure, oversight of quality control, staff management and development, assuring the successful conduct of patient-focused and also healthy volunteer clinical trials. Furthermore, there are 172 clinical trials sites, inspected and certified by Korea Ministry of Food and Drug Safety, as of Apr. 2015.
Out of 22 CTCs, 16 were selected to form 5 consortia for Global Centers of Excellence program to develop regional and national network for clinical research and to boost early phase clinical trials in Korea. More specific objectives of consortia include, for example, acceleration of early phase clinical trials including First-in-Human(FIH) and Proof-Of-Concept(POC) trials, specialization and globalization through clinical technology development such as genomics and metabolomics based personalized medicine.
This program is managed through Korea Clinical Trials Global Initiative(KCGI), the R&D Project run by KoNECT and funded by Ministry of Health and Welfare.
Patient protection and the quality of all clinical trials conducted in Korea are overseen not only by the Korean health authorities, but also international accrediting agencies. Several CTCs in Korea have been designated as preferred clinical trials sites by a number of global biopharmaceutical companies and CROs such as Sanofi, MSD, Quintiles, and Parexel etc., for early phase trials including First in Human(FIH) studies as well as more complex early to late phase trials.
In terms of clinical trials site numbers, the global trend is downward by -14%(2010-2014 CAGR, clinicaltrials.gov) while Korea shows +6.8% over the same period. Korea ranks 11th in 2014 globally in the number of clinical trials sites for Industry Sponsored Trials, 3rd largest after Japan and China.
South Korean society has traditionally placed an overwhelming emphasis on the importance of education and now benefits from a highly skilled labor force, with the highest global percentage of 25-34 year olds holding a tertiary education degree.
The Korean government operates a number of funding programs designed to support overseas educational opportunities for Korean doctors and clinical staff. As a result, Korean clinical trials sites have access to a steady stream of highly educated medical and research staff, many of whom have received training abroad especially in US and Europe.
The Health Ministers of Korea, Japan and China met in Seoul on Apr. 8th 2007 and built basic consensus for future cooperation on the health and medical field. One of the topics discussed for collaboration is to enhance new drug development, especially clinical development. The initiative is to conduct global clinical trials in East Asian Countries by accumulating the data on ethnic factors and to map out strategies to accelerate clinical development and approval review leveraging the data among the three countries.
Data acceptance by Japan of clinical data from non-Japanese patients has resulted in expansion in Asian regional studies sponsored by Japanese pharmaceutical companies. The Korea/Japan/China Tripartite Cooperation, a joint research project on ethnic factors in clinical data, promotes scientific research cooperation on ethnic factors in clinical data with a view to encourage global development and sharing of clinical data. This may help facilitate drug development and registration in East Asia.
Considering the number of protocols for Asia only clinical trials, Korean ranked No. 1, followed by Taiwan, China and Japan.(source: clinicaltrials.gov 2013)
More than half of the country’s 51 million residents live within one hour's drive from Seoul’s metropolitan region and the surrounding Gyeonggi Province. Busan is the second largest city situated on the southeast of the peninsula and is the fifth largest port in the world by trade volume. These two cities are connected by high speed rail link, allowing fast and convenient travel spanning the length of the country in less than three hours. Most residents can therefore travel to any major clinical trials site in the big cities and return home before nightfall.
Korea is ranked 2nd on the Global Innovation Index[Reference: Global Innovation Index, Boston Consulting Group and the National Association of Manufacturers ], and has highest 4G LTE penetration and greatest smart phone usage per capita with the world’s fastest internet. CTCs are equipped with high-tech Electronic Medical Record(EMR) system and integrated clinical data repository is accessible for research purposes.