[Opinion] Clinical Trial Powerhouse

The Finnish scientist Johannes Fibiger (1867~1928) conducted a modern clinical trial for the first time in history and received a Nobel Prize in medicine in 1926 for artificially producing cancer through clinical tests on animals. In 1898, he divided his patients into two groups to study effects of serum treatment on diphtheria. He conducted a serum treatment of diphtheria for one group and did not for the other. It was the first controlled clinical test that experts still consider impeccable by today’s standards.

Clinical trials are a must in developing a new drug. Usually, animal testing precedes clinical trials on humans. Such trials have very complicated processes and stringent ethical standards. If they fail to conform with the International Conference on Harmonization (ICH), even a newly developed drug with a proven efficacy will not be approved. Even in the U.S., the leader in the clinical trial field, only 10 percent of those who apply are certified by the authorities.

Only a handful of countries are capable of conducting clinical trials, which meet such stringent standards. Korea has emerged as a new leading clinical trial market among multinational pharmaceutical companies. MSD launched the first phase of clinical trial for developing a targeted therapy for stomach cancer in Korea and Japan. GSK is scheduled to begin a clinical trial in Korea very soon to see if the kidney and ovarian cancer treatment Hycamtin works for liver and kidney malfunctions as well.

There is fierce competition in the 40-trillion-won clinical trial market. The U.S. is an established leader in the market and conducts 70 percent of the world’s clinical trials, followed by Australia with a 200-billion-won market, or about 700 cases a year. India is also rapidly catching up on Korea. Multinational pharmaceutical firms conducted 108 clinical trials in Korea last year, which is a significant growth from five cases in 2000.

Such trials are becoming a new source of profit for hospitals with financial difficulties. Some 10 hospitals, including Seoul National University Hospital, rushed to open a clinical trial center recently. The emergence of Korea as a new leader in the clinical trial area means that the country’s advanced medical sector is recognized by the world. It is a ray of hope for the country’s medical sector as well.

Chung Sung-hee, Editorial Writer, shchung@donga.com