REVIEW ARTICLE
31 December 2015

New initiatives for transforming clinical research in Korea

Deborah Chee1* Min Soo Park2,3 Ji-Hoon Sohn1
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1 Korea National Enterprise for Clinical Trials (KoNECT), Seoul, 04143, Korea
2 Severance Hospital, Yonsei University College of Medicine, Seoul, 03722, Korea
3 Korea Clinical trials Global Initiative (KCGI), Seoul, 04143, Korea
JMDS 2017 , 2(1), 27–32; https://doi.org/10.18063/jmds.v1i2.134
Submitted: 26 October 2015 | Accepted: 22 December 2015
© 2017 by the Author(s). Licensee Whioce Publishing, Singapore. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution -Noncommercial 4.0 International License (CC BY-NC 4.0) ( https://creativecommons.org/licenses/by-nc/4.0/ )
Abstract

Korea has continuously sought to improve its regulatory environment for clinical trials and has invested heavily in clinical trial infrastructure and technology since the early 2000’s. A strategic investment through the Korea National Enterprise for Clinical Trials (KoNECT) program began in 2007 and grew to encompass a network of regional clinical trial centers to promote clinical trial capabilities and human resource development. In early 2014, KoNECT became a permanent organization focused on the advancement of the country's clinical trial industry. This was followed by the establishment of the Korea Clinical Trials Global Initiative (KCGI) and the KoNECT Collaboration Center for global clinical trials (KCC). KCGI and KCC are now at the forefront of KoNECT’s efforts to promote higher operational efficiency in the country’s clinical trials. These new initiatives in clinical research are undertaking multichannel approaches to pursue a cohesive international collaboration model between government, industry and academia for the development of new treatments and improved patient care.

Keywords
Korea clinical trials
new KoNECT
KCGI
KoNECT Collaboration Center
KIIS
References

1. Shin, S. (2011). The current status and policy of early stage clinical trials in Korea. Clin Eval, 39(2), 367–375.
2. Korea National Enterprise for Clinical Trials (KoNECT) home page. Retrieved December 14, 2015, from <www.konect.or.kr>
3. Khaleel, S. (2014). South Korea: Sprinting clinical trial development. Clinical Leader. Retrieved December 14, 2015, from <http://www.clinicalleader.com/doc/south-korea-sprinting-clinical-trial-development-0001>
4. Berthier, M., & McMillan, D. (2015). Making feasibility more reliable in clinical trials. epm Magazine. Retrieved October 17, 2015, from <http://www.epmmagazine.com/opinion/making-feasibility-more-reliable-in-clinical-trials/>
5. Miseta, E. (2015). Proper feasibility planning is critical for clinical trial success. Clinical Leader. Retrieved October 17, 2015, from <http://www.clinicalleader.com/doc/proper-feasibility-planning-is-critical-for-clinical-trial-success-0001>
6. Gehring, M., Taylor, R. S., Mellody, M., et al. (2013). Factors influencing clinical trial site selection in Europe: The survey of attitudes towards trial sites in Europe (the SAT-EU Study). BMJ Open, 3(11), e002957. <http://dx.doi.org/10.1136/bmjopen-2013-002957>
7. Ayalew, K. (2013). FDA perspective on international clinical trials. U.S. Food and Drug Administration. Retrieved October 14, 2015, from <http://www.fda.gov/downloads/Training/ClinicalInvestigatorTrainingCourse/UCM378499.pdf>
8. KoNECT Collaboration Center home page. Retrieved December 14, 2015, from <http://kcc.konect.or.kr/>

Conflict of interest
KoNECT is a non-profit organization funded by the Korean Ministry of Health and Welfare (MOHW) with a mission to nurture the country’s clinical trial infrastructure and capabilities.
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