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논문검색

국내·외 첨단재생의료 문헌 분석 : 연구자 주도와 의뢰자 주도 임상연구를 중심으로

원문정보

Analysis of Advanced Regenerative Medicine Literature : Focusing on Researcher-Led and Pharmaceutical Company-Led Clinical Research

이지연, 오정인, 윤동원, 박소희, 최은영, 송재환, 정선영, 오정자, 김화정, 신주영

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초록

영어

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.

목차

Abstract
서론
본론
연구방법
연구결과
첨단재생의료 임상연구 문헌 선정
첨단재생의료 임상연구 문헌 분석 결과
고찰 및 결론
References

저자정보

  • 이지연 Ji Yeon Lee. 성균관대학교 약학대학
  • 오정인 Jeong-in Oh. 성균관대학교 약학대학
  • 윤동원 Dongwon Yoon. 성균관대학교 약학대학, 성균관대학교 바이오헬스 규제과학과
  • 박소희 Sohee Park. 성균관대학교 약학대학
  • 최은영 Eun-Young Choi. 성균관대학교 약학대학
  • 송재환 JaeHwan Song. 성균관대학교 약학대학
  • 정선영 Sun-Young Jung. 중앙대학교 약학대학
  • 오정자 Jeong-Ja Oh. 사이넥스
  • 김화정 Hwa Jung Kim. 서울아산병원/울산대학교 의과대학
  • 신주영 Ju-Young Shin. 성균관대학교 약학대학, 성균관대학교 바이오헬스 규제과학과

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