South Korea Beefs Up Infrastructure To Lead Asia In Early-Stage Clinical Trials

SEOUL - South Korea is drawing more Phase I and Phase II clinical trials from its former foothold in Phase III and post-approval trials, Korea National Enterprise for Clinical Trials reported.

"Until 2006, Phase III were the main clinical trials we had done, but we began to undertake [more] Phase I and Phase II trials beginning in 2007 as our clinical trial level and standards became recognized," KoNECT President Shin Sang-goo told PharmAsiaNews.

Shin said South Korea conducts the most Phase II trials in Asia, while Singapore leads the way in Phase I trials.

"I think South Korea can and should move forward for more Phase I and Phase II trials in the future while China and India do more Phase III trials, taking advantage of their strong points such as large populations," Shin said. "We are trying to make South Korea more of an attractive spot for clinical trials, as it is well armed with high medical standards, accuracy and good quality of clinical trials."

Of the 216 clinical trials approved in 2008 for multinational companies, Phase I and Phase II trials stood at 15 and 58 cases respectively, pointing to an "upward trend" compared to 7 Phase I trials and 45 Phase II trials in 2007. Phase III trials in 2008 stood at 135, compared to 95 in 2007. Post-approval trials in 2008 were 8, compared to one in 2007.

Korea FDA approval of clinical trials for MNCs began to rise sharply beginning in 2005 when clinical trial approvals rose to 95 cases from 61 cases in 2004, 46 cases in 2003 and 17 cases in 2002. In 2006, approvals soared to 108 cases and to 148 cases in 2007 (Also see "Multinationals Step Up Clinical Trials In South Korea" - Scrip, 9 Jan, 2008.).

A professor of clinical pharmacology of Seoul National University Hospital & School of Medicine, Shin is serving his second year in a six-year term as the president of KoNECT, which was set up in Dec. 2007 by the Ministry of Health, Welfare and Family Affairs.

South Korea began to increase its efforts to draw more clinical trials into the country five years ago by selecting 12 large general hospitals for clinical trial centers in various regions of Korea.

The 12 universities, which include Seoul National University and Yonsei University, and other state universities, invest KRW 4 billion ($2.87 million) each year for their clinical trials centers in what Shin called "matching funds" for government funding. The government in turn supports each hospital with KRW 4 billion annually for five years under its slogan, "Korea , the hub of global clinical trials."

By enhancing clinical trial power at the universities and providing a competitive cost compared to Singapore and Australia, South Korea hopes to become the leading player in Asia over Australia, India and China, Shin said.

South Korea now ranks 25th in clinical trials, trailing Australia, which is 11th, India at 16th and China at 23rd.

"South Korea is the second Asian country which initiated good clinical practices in 1995 after Japan started that in 1990," said Shin, adding that excellent manpower and speedy clinical trials performance would continue to make South Korea an attractive hub for clinical trials.

Noting that cancer, cardiovascular and central nervous system diseases are the major therapy areas for trials currently being conducted at the 12 universities, Shin said diversification in global clinical trials by MNCs has lead to increased competition among nations and hospitals to participate in global trials.

To counter growing global competition, Shin said KoNECT is moving to add three more clinical centers to the current 12 centers as part of its drive to bring in KRW 1 trillion compared to last year's KRW 300 billion from MNCs by 2013 for clinical trials.

To that effect, Shin said KoNECT is conducting various types of training programs to enhance the South Korean workforce, including programs in human resources training, clinical research associates, database manager training, clinical investigator training and biostatistician specialist programs.

KoNECT has also helped introduce new clinical trial technology such as pharmacodynamic modeling and clinical trial simulation technology, clinical trial technology using pharmacogenomic data and development and practical use of biostatistics methodologies to design and analyze trials, Shin said.

The National Cancer Center and Advanced Institute of Convergence Technology of South Korea - both government-sponsored bodies - recently announced they would be teaming up for research and development of cancer drugs that will meet international standards, in part to boost the local economy (Also see "South Korean Government Bodies Team Up For Cancer Drug Development" - Scrip, 5 Feb, 2008.).

South Korean President Lee Myung-bak in January named "17 new growth engines" expected to spearhead the country's economic growth for the next 10 years - of those 17 economic growth engines, the Korean government targeted biologics, medical devices and global health care among the national priorities (Also see "Korea Targets Biologics, Devices, Health Care Among Economic Growth Projects For Next Decade" - Scrip, 16 Jan, 2009.).

- Peter Chang ([email protected])