초록 ▼

연구결과
필요성 및 목표
○ 국제적으로 임상시험의 윤리성 및 과학성 객관성 강화를 위해 임상시험 등록을 의무화하는 추세에 따라, 국내에서 수행되고 있는 임상시험 등록을 활성화 할 필요가 있음
○ 또한 국내 및 다국가 임상시험 횟수가 꾸준히 증가함에 따라 효율적인 임상 수행을 위해 대행기관 도입 등이 필요
방법 및 결과
○ 국가별 임상시험 등록제도 관련 문헌조사 수행
○ 임상시험 등록 의무화 제도에 대한 인식도 조사 수행
○ 국내외 임상시험 대행기관의 현황에 대한 문헌조사 및 방문조사 수행

연구결과
필요성 및 목표
○ 국제적으로 임상시험의 윤리성 및 과학성 객관성 강화를 위해 임상시험 등록을 의무화하는 추세에 따라, 국내에서 수행되고 있는 임상시험 등록을 활성화 할 필요가 있음
○ 또한 국내 및 다국가 임상시험 횟수가 꾸준히 증가함에 따라 효율적인 임상 수행을 위해 대행기관 도입 등이 필요
방법 및 결과
○ 국가별 임상시험 등록제도 관련 문헌조사 수행
○ 임상시험 등록 의무화 제도에 대한 인식도 조사 수행
○ 국내외 임상시험 대행기관의 현황에 대한 문헌조사 및 방문조사 수행
기대성과
○ 국내 임상시험 등록 개선을 통한 국내 임상시험정보의 공유 및 임상시험 피험자 보호 강화
○ SMO 등 대행기관 도입을 통한 임상 수행의 효율성 제공

Abstract ▼

With international trends of reinforced requirements for safety and efficacy of new drugs and increased demand for multinational clinical trials, the investment in clinical trials around the world is presumed to be 8.6 billion as of 2011 (total investments made by 500 pharmaceutical companies) and c

With international trends of reinforced requirements for safety and efficacy of new drugs and increased demand for multinational clinical trials, the investment in clinical trials around the world is presumed to be 8.6 billion as of 2011 (total investments made by 500 pharmaceutical companies) and continued growth is expected (about 2% per year).Since this clinical trial field is a high value-added industry characterized by technology-intensiveness, developed countries have tried to improve regulatory systems and increase investment. Although developed countries, such as USA and Europe, are leading this clinical trial industry, radical growth in Asian and South American countries are expected owing to reduction in cost of clinical trials,development of medical technology and increase in infrastructures.
When considering such international trends, it is necessary to assure transparency and objectivity in clinical trials, increase the confidence in clinical trial results and solve many problems, such as insufficient training and experience of clinical trial investigators, in order to become a global leader in the field of clinical trials. In addition, it is highly important to accomplish our own competitiveness and develop the government's regulatory supports.WHO, USA, EU and other developed countries have established the clinical trial registration system in order to assure the transparence in clinical trials and to accomplish objective clinical trial results, such as "ClinicalTrials.gov" (USA) and "EU-CTR (EudraCT)" (EU). At present, the number of clinical trials registered at "ClinicalTrials.gov" is about 170,000, while the number of clinical trials registered at "EU-CTR (EudraCT)" is about 40,000.
Also, the Korea National Institute of Health developed a system for registration of clinical trials called "CRIS (ClinicalResearch Information Service)" in 2010. However, this system requires registration of only clinical trials conducted with supports from the Ministry of Health and Welfare. Therefore, when compared to the number of clinical trials approved by the Ministry of Food and Drug Safety, the percentage of registered clinical trials is very low. Meanwhile, with the increased number of clinical trials in Korea and the reinforcement of international requirements for clinical trials, it is highly important to effectively respond to changes of local and international requirements and ensure quality assurance in clinical trials. In addition, the importance and role of contract research organization with qualified professionals have been highlighted and the demand for such organizations has been increased.
Accordingly, this study was conducted to develop measures for activation of clinical trial registration, in order to reinforce the ethics and scientific objectivity in clinical trials. In addition, a proposal for introduction of contract research organizations for clinical trials is provided in order to improve the efficiency of clinical trials under consideration of local circumstances and increase in multinational clinical trials.In order to develop measures for activation of local clinical trial registration, local and foreign laws and regulations relating to clinical trials were comparatively analyzed and registration systems were investigated. In addition, an advisory committee consisting of experts from industry, academy, research and government was organized to collect opinions.
Further, about 500 persons engaged in clinical trials were contacted to collect information on local clinical trial registration system, in order to develop measures for efficient system and propose policies for clinical trials.Meanwhile, local and foreign contract research organizations were investigated and expert meetings were held to collect opinions for improved quality, cost reduction and efficient performance of clinical trials. Then, SWOT analysis was conducted for local contract research organizations and mid to long-term strategies were developed.Finally, a "Korean CRO model" was proposed to introduce the system for contract research organization for clinical trials.

목차 Contents

• 표지 ... 1
• 자체연구개발과제 최종보고서 ... 2
• 국문요약문 ... 3
• Summary ... 5
• 목차 ... 7
• 임상시험 등록 및 운영 개선 방안 연구 요약서 ... 10
• 제1장 연구개발과제의 개요 ... 23
• 1. 연구개발과제의 목표 ... 23
• 2. 연구개발과제의 필요성 ... 23
• 제2장 연구개발과제의 국내․외 연구개발 현황 ... 28
• 1. 임상시험 등록제도 ... 28
• 1) 국외 ... 28
• 2) 국내 ... 30
• 2. 임상시험 대행기관 ... 31
• 1) 국외 임상시험 대행기관 현황 ... 31
• 2) 국내 임상시험 대행기관 현황 ... 31
• 제3장 연구개발과제의 연구수행 내용 및 결과 ... 32
• 1. 연구개발 내용 ... 32
• 1) 임상시험 등록 및 운영개선 ... 32
• 2) 임상시험 대행기관 도입 ... 32
• 2. 연구개발 방법 ... 33
• 1) 임상시험 등록 및 운영개선 ... 33
• 2) 임상시험 대행기관 도입 ... 33
• 3. 연구결과 ... 34
• 1) 임상시험 등록 및 운영개선 ... 34
• 2) 임상시험 대행기관 도입 ... 84
• 제4장 연구개발과제의 연구결과 고찰 및 결론 ... 126
• 제5장 연구개발과제의 목표달성도 및 관련분야에의 기여도 ... 129
• 1. 연구개발과제 목표달성도 ... 129
• 2. 관련분야 연구 등에 대한 기여도 ... 129
• 1) 국내 임상시험 등록 활성화와 제도적 개선을 위한 기반자료 확보 ... 129
• 2) 임상시험 대행기관 도입 방안 마련으로 임상 수행의 효율성 제고 ... 129
• 제6장 연구개발과제 연구개발 결과 활용계획 ... 130
• 제1절 활용성과 ... 130
• 제2절 활용계획 ... 130
• 가. 정책활용 ... 130
• 나. 언론홍보 및 대국민교육 ... 130
• 다. 연구논문 ... 130
• 라. 학술발표 ... 130
• 마. 지식재산권 ... 130
• 제7장 참고문헌 ... 131
• 제8장 첨부서류 ... 133
• 끝페이지 ... 307