Review of the Registration in the Clinical Research Information Service.
- Author:
Eun Kyoung CHOI
1
;
Mi Jung KIM
;
Nam Kyoo LIM
;
Hyun Young PARK
Author Information
- Publication Type:Original Article ; Research Support, Non-U.S. Gov't ; Review
- Keywords: Clinical Trials as Topic; Databases, Factual; Information Dissemination; Internet; Registries; Republic of Korea
- MeSH: Biomedical Research; Clinical Trials as Topic; Databases, Factual; Humans; *Information Services; Internet; Registries; Republic of Korea
- From:Journal of Korean Medical Science 2016;31(1):1-8
- CountryRepublic of Korea
- Language:English
- Abstract: Clinical research registration is required in many countries to improve transparency of clinical research and to ensure subject safety. Developed in February 2010, the Clinical Research Information Service (CRIS) is an online registration system for clinical studies in Korea and one of the primary registries of the World Health Organization (WHO) International Clinical Trials Registry Platform. The present analysis investigated the characteristics of studies registered in the CRIS between February 2010 and December 2014. Data for the analysis were extracted from the CRIS database. As of December 31, 2014, 1,323 clinical studies were registered. Of these, 938 (70.9%) were interventional studies and 385 (29.1%) were observational studies. A total of 248 (18.7%) studies were funded by government sources, 1,051 (79.4%) by non-government sources, and 24 (1.8%) by both. The most frequently studied disease category based on the ICD-10 classification was the digestive system (13.1%), followed by the nervous system (9.4%) and musculoskeletal system (9.1%). Only 17.8% of the studies were registered prior to enrollment of the first subject. Comparing the number of registered or approved clinical studies between the CRIS, the Ministry of Food and Drug Safety, and ClinicalTrials.gov suggests that a considerable number of clinical studies are not registered with the CRIS; therefore, we would suggest that such registration should be the mandatory legal requirement.
