The number of clinical trials (phase 1 – phase 3) has decreased for two consecutive years worldwide.
Despite the decline in clinical trials, the global market share of Korea’s clinical trials increased 5.3 percent from a year ago to 2.19 percent in the first half of 2017.
Korea National Enterprise for Clinical Trials한국임상시험산업본부 (KoNECT, CEO Ji Dong-hyun지동현) has recently released its analysis of clinical trial registration of medicinal products as tallied by the U.S. National Institute of Health (NIH)’s “Clinical Trials.gov” in the first six months of this year.
The number of global clinical trials for new drugs fell 22.5 percent from the first half of 2016, and the number of Phase 1 and Phase 3 drug trials for new drug development recorded a sharp drop of 32.8 percent.
The trend of declining clinical trials was uniform over phase 1, 2 and 3 but the drop was steeper in phase 2 (-51.3 percent) and phase 3 (-38.7 percent) than in phase 1 (-29.0 percent).
The United States took the lead in reducing the number of clinical trials, recording decreases of about 40 percent through phase 1, 2, and 3, adversely affecting the declines in phase 2 and 3 clinical trials in the rest of the world, KoNECT said.
Korea also showed a 29.3 percent decrease in clinical trials led by pharmaceutical companies in the first half of this year. However, the global market share of clinical trials in Korea increased from 2.08 percent in the first half of 2016 to 2.19 percent in 2017, an increase of about 5.3 percent.
In the first half of this year, multinational clinical trials accounted for 56.2 percent of all clinical trials, up 2.5 percent from 2016.
The number of participating sites per clinical trial protocol also increased 17.7 percent to 9.69, compared with 8.23 a year earlier.
In the first half year, phase 3 trials took the largest portion with 40.4 percent, followed by phase 2 with 22.7 percent, and phase 1 with 21.6 percent.
The global market share of multinational clinical trials in Korea increased from 2.10 percent in 2016 to 2.33 percent in 2017, an increase of about 11.0 percent. Korea also had the largest share of the phase 3 trials while that of phase 2 trials was relatively small. Multinational clinical trials in Korea showed the proportions of 26.1 percent for phase 1, 13.5 percent for phase 2, and 47.4 percent for phase 3 trials.
Global clinical trials are expected to fluctuate due to the relative sluggishness of the U.S. and Western European countries and rising performances in China and Japan, according to KoNECT.
Meanwhile, the number of clinical trials approved by the Ministry of Food and Drug Safety 식품의약품안전처from January to June was 352, 19.3 percent higher than the 295 a year ago.
Among them, the number of clinical trials approved for pharmaceutical companies and contract research organizations (CRO) increased to 240 cases, up 24 cases, or 11.1 percent, from 216 a year earlier.
The number of clinical trials applied for by foreign companies was 32, and most of the increases were multinational clinical trials.
Also, the number of approvals for international CROs grew 26.9 percent to 60 cases, compared with 52 a year ago. This suggests that there are more and more foreign developers of new drugs wanting to conduct clinical trials in Korea.
Researchers' clinical trials totaled 112 cases, up 41.8 percent from 79 a year ago. Samsung Seoul Hospital삼성서울병원 conducted 19 of them, followed by 12 each by Severance Hospital세브란스병원 and Seoul National University Hospital서울대학교병원, Asan Medical Center’s서울아산병원 eight.
Among clinical trials approved by the food and drug safety ministry식품의약품안전처 this year, phase 1 accounted for 36.7 percent, phase 2 accounted for 14.6 percent and phase 3 accounted for 48.8 percent, indicating noticeable increases in the early-phase trials by domestic drugmakers and late-phase tests by multinational pharmaceuticals, KoNECT said.
Multinational clinical trials totaled at least 147, up 24.5 percent from 119 a year earlier, but the agency failed to classify the share of multinational trials by domestic companies as it could not confirm data.
"The global clinical trial industry is becoming increasingly difficult to predict because of the changing paradigms of new drug development and changes in clinical trial strategies. Even in this rapidly evolving trend, Korea is maintaining its competitiveness in clinical trials,” CEO Ji said.
“Clinical trials are essential for current and future patients’ access to new drugs,” he said. “To maintain Korea's competitiveness in clinical trials, we will continuously improve the clinical trial system for patients' safety, continue to develop the clinical trial approval system that takes into consideration global trends for investment and training of the professional clinical trial workforce.”
The development and support of various national initiatives to attract high-quality clinical trials are critical and urgent, Ji added.