초록 ▼

- 한의약임상시험 전용공간 및 연구전담인력 확보
- 한의약 임상시험 전용장비 구축 및 활용
- 한의약임상시험센터 조직 및 운영 SOP 마련 등 운영체계 구축
- 웹기반임상시험관리시스템(eIRB, eCRF 등)을 포함한 자료관리시스템 구축
- FERCAP 국제인증
- 국내외 한의약 임상시험 유관기관 업무협약 체결 및 산학연병 네트워크 구축
- 임상시험 지원서비스 및 임상연구과제 수주 확대를 통한 센터 활성화 모델 개발
- 한의약 임상연구 전문가 양성을 위한 교육 프로그램 개발/운영 및 온라인 교육

- 한의약임상시험 전용공간 및 연구전담인력 확보
- 한의약 임상시험 전용장비 구축 및 활용
- 한의약임상시험센터 조직 및 운영 SOP 마련 등 운영체계 구축
- 웹기반임상시험관리시스템(eIRB, eCRF 등)을 포함한 자료관리시스템 구축
- FERCAP 국제인증
- 국내외 한의약 임상시험 유관기관 업무협약 체결 및 산학연병 네트워크 구축
- 임상시험 지원서비스 및 임상연구과제 수주 확대를 통한 센터 활성화 모델 개발
- 한의약 임상연구 전문가 양성을 위한 교육 프로그램 개발/운영 및 온라인 교육시스템 구축
- 한의약 관련 제품화 임상시험기술 지원체계 구축
- 한의약 임상시험 규정 및 가이드라인 개발 및 관련 학회 인증
- 한의약 임상시험 평가도구 및 실시기술 개발
- 한의약 임상시험 기술을 적용한 단일기관, 다기관 임상시험 시범수행
- 한의약 종양특화 중개연구 및 임상시험기술 개발
- SCI(E) 논문 25편을 포함하여 국내외 총90편 논문 게재, 국내 특허 2건 출원, 1건 등록

(출처 : 요약서 3p)

Abstract ▼

Purpose&Contents
□ Establishments of Korean Medicine clinical study infrastructures
□ Establishments of industry-academy-institution-hospital network
□ Development of educational program for Korean Medicine clinical study
□ Establishments of commercialization supporting system
□ Devel

Purpose&Contents
□ Establishments of Korean Medicine clinical study infrastructures
□ Establishments of industry-academy-institution-hospital network
□ Development of educational program for Korean Medicine clinical study
□ Establishments of commercialization supporting system
□ Development and operation of Korean Medicine clinical trial technique
□ Establishment of Korean Medicine oncology-specialized clinical study system

Results
□ Securement of exclusive space (825.82㎡) and 21 personnel/professionals including full-time positions in Korean Medicine Clinical Research Center-Daejeon Korean Medicine Hospital of Daejeon University.
□ Furnishing research-exclusive facilities/equipment
□ Composition of independent organization and standard operating procedures (SOPs)
□ Development of data management system including web-based clinical trial management system (eIRB, eCRF, etc.) for standardized clinical trials
□ International certification of FERCAP to enhance the quality of Korean medicine clinical trials
□ Establishing the Korean Medicine Clinical Trial Center Council and networking with various institutions with domestic and international clinical trial centers
□ Suggesting a plan to develop and utilize the results of the establishment clinical infrastructure of Korean Medicine based on a survey conducted to a clinical research institute of Korean medicine
□ Development of education for Korean Medicine clinical research experts and operating E-learning system
□ Establishments of commercialization supporting system (3 consulting, 1 symposium)
□ Development of clinical trial guidelines for Korean Medicine drugs (acute bronchitis, depression)
□ Development of Korean Medicine Diagnostic Evaluation (KMDE) tool (benign prostatic hyperplasia, polycystic ovary syndrome, Insomnia, gonarthrosis, health assessment)
□ Implementation of 6 tool validation, 1 drug-interaction, 8 single- and 3 multi-center clinical trials including 2 IND trials on Korean Medicine
□ Implementation of international clinical trial guidelines for Korean Medicine drugs (depression)
□ Establishment of 3 Korean medicine cancer therapeutic modality and 2 translational research
□ Construction and implement of Cancer Registry and Prospective Korean Medicinal Intervention Cohort Study
□ Approval of phase 2 IND and implementation of multi-center Korean medicinal intervention clinical trials for cancer
□ Publication of a total of 90 scientific articles including 25 SCI(E) papers and application for 2 patents and registration of 1 patent on Korean Medicine techniques in Korea

Expected Contribution
□ Continuing research through the established system of clinical trial center, medical device, and internal and external utilization of manpower
□ Utilization as a foundation for practical training for the training experts in clinical trial based on established education system (online)
□ Acting as a multi-center and multi-national clinical research center by utilizing domestic and foreign industry-academy-institution-hospital network and web-based clinical trial systems
□ Activating the Korean Medicine industry and creating community employment through the utilization of clinical trial infrastructure
□ Contributions to the improvement of the quality of Korean Medicine treatment and the promotion of the life quality of the people through securing the reliability and validity of Korean Medicine

(출처 : SUMMARY 5p)

목차 Contents

• 표지 ... 1
• 제 출 문 ... 2
• 보고서 요약서 ... 3
• 국문 요약문 ... 4
• SUMMARY ... 5
• Table of Contents ... 6
• 목차 ... 7
• 1. 연구개발과제의 개요 ... 8
• 2. 국내외 기술개발 현황 ... 12
• 3. 연구수행 내용 및 결과 ... 15
• 1세부 연구개발 실적 ... 15
• 2세부 연구개발 실적 ... 67
• 3세부 연구개발 실적 ... 111
• 4세부 연구개발 실적 ... 182
• 4. 목표달성도 및 관련분야 기여도 ... 232
• 4-1. 목표달성도 ... 232
• 4-2. 관련분야 기여도 ... 237
• 5. 연구결과의 활용계획 ... 238
• 6. 연구과정에서 수집한 해외과학기술정보 ... 239
• 7. 연구개발성과의 보안등급 ... 248
• 8. 국가과학기술종합정보시스템에 등록한 연구시설·장비 현황 ... 249
• 9. 연구개발과제 수행에 따른 연구실 등의 안전조치 이행실적 ... 250
• 10. 연구개발과제의 대표적 연구실적 ... 251
• 11. 기타사항 ... 252
• 12. 참고문헌 ... 268
• [별첨4] 실적 증빙자료 ... 269
• [별첨5] 사업성과 요약서 ... 325
• [별첨6] 과제기본정보 서식 ... 326
• 끝페이지 ... 327