J Korean Med Sci.  2016 Jan;31(1):1-8. 10.3346/jkms.2016.31.1.1.

Review of the Registration in the Clinical Research Information Service

• Choi EK
• Kim MJ
• Lim NK
• Park HY

• KMID: 2359984
• DOI: http://doi.org/10.3346/jkms.2016.31.1.1

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.

Keyword

Clinical Trials as Topic; Databases, Factual; Information Dissemination; Internet; Registries; Republic of Korea

MeSH Terms

Biomedical Research
Clinical Trials as Topic
Databases, Factual
Humans
*Information Services
Internet
Registries
Republic of Korea

Figure

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  Fig. 1 Registration process in the CRIS and information sharing with WHO ICTRP. CRIS, Clinical Research Information Service; WHO ICTRP, World Health Organization International Clinical Trials Registry Platform.

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  Fig. 2 Classification of research types of registered clinical research by funding source. Data are expressed as No. (%). *The other government funding sources were included except the MOHW; †Non-profit organizations and academic associations were included; ‡The researches were funded both by government source(s) and non-government source(s). MOHW, Ministry of Health and Welfare.

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  Fig. 3 Classification of the registered research by intervention. Data are expressed as No. (%). *Drug includes biological and vaccine; †Combined intervention includes more than two interventions; ‡Others include behavioral therapy, dietary supplement, radiation therapy and non-listed interventions.

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  Fig. 4 Accumulated number of registered clinical researches in the CRIS. CRIS, Clinical Research Information Service.

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