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KMID : 0363420190330010017
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Journal of Korean Oriental Pediatrics
2019 Volume.33 No. 1 p.17 ~ p.33
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Review of Registration of Interventional Studies of Children and Adolescents in Korea
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Lee Yoo-Been
Lee Ju-Ah
Lee Hye-Lim
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Abstract
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Objectives : The purpose of this study is to investigate the current status of registration of interventional studies focusing on children and adolescents in South Korea and the status of Korean medicine interventional studies through Clinical Research Information Service (CRIS).
Methods : CRIS was used to search interventional clinical researches which were registered from May, 2010 to October, 2018. Key words of ‘child’, ‘children’, ‘adolescents’, ‘infant’, ‘toddler’, ‘elementary school student’, ‘middle and high school’, ‘middle school student’, and ‘high school student’ were used.
Results : A total of 37 intervention clinical studies were selected. To identify the trends, years of registration in the CRIS, intervention types, disease categories, recruitment status, phase, institutions responsible for the research, consent, compensation and safety investigation were analyzed.
Conclusions: This study shows the current state of registration of interventional studies in children and adolescents in Korea. Since interventional studies in children and adolescents are essential for providing safe and effective treatment, further interventional studies, Korean medicine interventional studies and ethical considerations are needed.
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KEYWORD
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Clinical research, Clinical trial, Interventional study, CRIS
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