Review of clinical studies registered with the Clinical Research Information Service


Kim Mi-Jung, Choi Eun-Kyoung, Park Hyun-Young
Division of Cardiovascular Disease, Center for Biomedical Science, KNIH, KCDC

Clinical research registration is required in many countries to improve the transparency of clinical research and to ensure the safety of subjects. In 2010, the Korea Centers for Disease Control and Prevention (KCDC) established the Clinical Research Information Service (CRIS), a non-profit online registration system for clinical research, joining in the World Health Organization’s International Clinical Trials Registry Platform (ICTRP) as a primary registry. The main purpose of the CRIS was to improve the transparency, accountability, and ethics in clinical research being conducted in Korea by sharing registered information with the public.
A total of 2,264 clinical studies were registered with the CRIS from 2010 through 1st quarter of 2017. Of the 2,264 registered studies, 1,632 (72.1%) were for interventional studies and 6632 (27.9%) for observational studies. The most frequent intervention types were drug/biological therapy (48.7%, n=794), medical device (13.1%, n=214), surgery/procedure (12.8%, n=209) and combined therapy (5.6%, n=91). In recent years, the necessity of registration of clinical trial results has been emphasized to prevent selective reporting of outcomes and reduce publication bias. Therefore the WHO ICTRP participating registries including the CRIS have added the entry items for rresults reporting, and we expect that the registration of clinical trials and their results contributes in helping people make decisions about health care services.