The Korea National Enterprise for Clinical Trials (KoNECT) announced on January 15 that the U.S. had the most clinical trials in the world, taking up nearly 24.5 percent of the clinical trial protocol market share, after its analysis of the clinical trials registered with the U.S. National Institutes for Health’s website ClinicalTrials.gov last year.
After the U.S., Germany came in second place with 5.3 percent, followed by the U.K. with 5 percent, Canada with 3.9 percent and China with 3.7 percent. South Korea ranked sixth in the world with a 3.5 percent market share, moving two notches up from the 8th at the previous year.
In particular, Seoul topped the list with the most clinical trials per city last year. It is meaningful in that the city shows a significant gap with Houston of the U.S., which took second place in the world.
Recently, the size of global clinical trials has been considerably falling due to a decrease in new drug candidates, a sharp increase in research and development investment costs caused by a loss of new drug development efficiency and stronger standards of clinical trials and new drug licenses by health authorities in each country. In fact, the number of global clinical trials went down 25.4 percent and 16.3 percent in 2016 and 2017 respectively, compared to the previous year.
However, the number of domestic clinical trials came to 658 in 2017, up nearly 31 percent from 2011. Its share in global clinical trials also grew from 3.41 percent in 2016 to 3.5 percent this year. The size of domestic clinical trials continues to show a rise from 503 in 2011 to 670 in 2012, 607 in 2013, 652 in 2014, 675 in 2015 and 628 in 2016.
Notably, the number of clinical trials led by multinational pharmaceuticals recorded at 248 in 2013, 285 in 2014, 296 in 2015 and 267 in 2016. In short, the domestic clinical trial market saw its global competitiveness grow. The number of clinical trials led by domestic pharmaceuticals over the same period stood at 248 in 2013, 285 in 2014, 296 in 2015 and 267 in 2016.
The number of global clinical trials in South Korea is increasing because of high quality of domestic medial institutions. Global pharmaceutical firms have been started conducting a clinical trial in South Korea from early 2000 in earnest.
Lim Young-suk, director of the Asan Medical Center's (AMC) Clinical Trial Center and professor in the Department of Gastroenterology, said, “Proving efficacy and safety of new drugs is the most important thing when global pharmaceutical companies carry out a clinical trial. It is also important to cut costs so they need medical institutions that can quickly register patients who are fit for the protocol of new drug development and quickly identify and deal with safety problems and then report them.”
Seoul in South Korea satisfies such requirements. About 35 percent of cancer patients across the nation are registered in large medical institutions in Seoul. The city has a big pool of patients. Therefore, there are many doctors who provide high-quality medical services and have an excellent ability to solve problems. This is why Seoul is the city that has the most number of clinical trials in the world. In addition, there are risks for pharmaceutical firms to scrap new drug development itself by mistake of clinical trial institutions, not by side effects of new drugs, when medical institutions conduct a clinical trial but have a poor quality of services.
Lim said, “It is encouraging that the number of a phase 1b clinical trial which global pharmaceuticals commission only top medical institutions has been showing a significant growth especially after 2015. As domestic medical institutions are used to conduct global standard clinical trials of global pharmaceuticals, clinical trial infrastructure can be a tremendous advantage when domestic pharmaceuticals develop new drugs.”
Ji Dong-hyun, CEO at the KoNECT, said, “South Korea puts up a good show in clinical trials. It means that the nation has proved its excellent clinical trial infrastructure and performance competency. As the government’s support is beginning to show results, we need to improve the ability of clinical trial development of government, industry and academia, advance regulations and introduce incentive systems in order to help domestically developed new drugs conduct a phase III clinical trial as well.