Korea completes ‘phase 0’ testing
Published: 26 Jan. 2010, 21:15
Previously, phase 0 clinical trials were mostly conducted by medical teams from EU countries, the U.S. or Japan. However with the success from the Yonsei team, local medical experts expect the Korean clinical trial market to blossom further.
Clinical trials for new drugs are often grouped into four phases, starting from phase 1 to phase 4. Phase 0 clinical trials, a fairly recent trial stage, is done before phase 1 and are aimed at testing whether the respective drug behaves the way it was expected on a molecular level based on preclinical studies.
Phase 0 trials are also known as “human microdosing studies” as the administration of doses during phase 0 are very low.
A drug cannot be declared both safe and effective unless early results are confirmed by much more extensive tests during later-stage clinical trials.
In the Korean phase 0 trial, a team led by professor Lee Jong-du at Yonsei University’s Severance Hospital announced that after performing a drug test on 12 breast cancer patients during PET (positron emission tomography) scanning procedures, the drug had the predicted effects.
The clinical trial for the drug was commissioned by U.S. imaging firm Siemens Molecular Imaging.
The drug was approved to be tested by the Food and Drug Administration last July.
During the last 10 years, Korea’s clinical trial market has seen rapid growth. In 1999, the Food and Drug Administration approved 31 clinical trials here. By 2009, this number rose to 400. But those were not the more difficult phase 0 trials.
The notion of being involved in clinical trials is also becoming more positive among Koreans. Some 67.4 percent of those surveyed, including hospital workers and families of patients, said that if a clinical trial for a new drug has been developed, they would be willing to participate, according to a survey conducted by the clinical trial research support center at the Catholic Medical Center.
Take the case of Jeon Sang-ho. The 56-year-old was diagnosed with stage four colorectal cancer and agreed to enroll in a clinical trial in 2007 for a new treatment administered by Professor Jang Dae-yeong’s team at Hallym University Sacred Heart Hospital.
Jeon said that when he received his diagnoses, he had just suffered a business failure and was in dire financial circumstances. He agreed to take place in the trial as a last hope.
With the new treatment, Jeon’s cancer almost completely disappeared after two years.
“Although it is too early to say that the patient is completely clear [of cancer] as it has been less than five years since his treatment, Jeon’s health at present is good, without too much fear that it will worsen,” said Jang.
The Seoul National University Hospital estimated that last year 280,000 people here participated in clinical trials.
Out of all clinical trials performed in Korea in 2006, 108 were commissioned by multinational pharmaceutical companies. Last year, the number rose to 202.
“The fact that foreign pharmaceutical companies are commissioning phase 0 to phase 2 clinical trials to medical teams in Korea means that the companies trust their level of expertise and want them to be involved in the development of their new drugs from the very first stages,” said Shin Sang-gu, head of the Korea National Enterprise for Clinical Trials.
Ten years ago, Korea wasn’t even on the radar of global clinical trial markets.
However last year, the country became one of the top-10 clinical trial markets worldwide. In Asia, Korea is the biggest such market after Japan, according to data from last year.
By Park Tae-kyun, Cho Jae-eun [[email protected]]
with the Korea JoongAng Daily
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