국내·외 첨단재생의료 문헌 분석

• 영문명: Analysis of Advanced Regenerative Medicine Literature: Focusing on Researcher-Led and Pharmaceutical Company-Led Clinical Research
• 발행기관: 한국사회약학회 (구.한국보건사회약료경영학회)
• 저자명: 이지연 오정인 윤동원 박소희 최은영 송재환 정선영 오정자 김화정 신주영
• 간행물 정보: 『한국사회약학회지』제10권 제2호, 98~103쪽, 전체 6쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2022.11.30

영문 초록

OBJECTIVES The purpose of this study is to understand the status of clinical research in advanced regenerative medicine, and to analyze each detailed item with a focus on researcher-led and pharmaceutical company -led clinical research. METHODS Among the documents registered in PubMed from 1 January 2018 to 29 June 2021, the clinical research literature was selected as the literature that corresponds to the advanced regenerative medicine clinical research and contains adverse reaction information. Publication year, country, indication type, and follow-up period were selected as variables to analyze clinical research literature by research funding. RESULTS As a result of the study, 220 eligible studies were identified through a literature search. 163 cases (74%) of researcher-led clinical research and 57 cases (26%) of pharmaceutical company -led clinical research were investigated. In the case of advanced regenerative medicine indications, researcher-led clinical research conducted overwhelmingly in clinical studies of brain/neuro/psychiatric diseases and eye diseases. As a result of analyzing the adverse events described in the entire clinical research literature, in the order of headache, nausea, fatigue, fever, and anemia were observed in pharmaceutical company-led clinical research and fatigue, prexia, headache, and hypertension in researcherled clinical research. CONCLUSIONS We expect this study will maximize the efficiency of clinical research information utilization and will help concentrate on building a safety management system.

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키워드

Regenerative Medicine Clinical Research Adverse Event Patient Safety