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Original Article
한국의 다지역 임상시험 가이드라인 적용에 대한 인식: 다중 이해관계자 설문조사
Perspectives on Adopting the Guideline for Multi-regional Clinical Trials in Korea: A Multi-stakeholder Survey
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- 발행기관
- 한국임상약학회 바로가기
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- 간행물
- 한국임상약학회지 KCI 등재 바로가기
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- 통권
- 제29권 제4호 (2019.12)바로가기
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- 페이지
- pp.267-277
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- 저자
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- 언어
- 영어(ENG)
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- URL
- https://www.earticle.net/Article/A366737
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원문정보
초록
- 영어
- Backgrounds: With the globalization of drug development, multi-regional clinical trials (MRCTs) have emerged to facilitate rapid availability of medicines to patients worldwide. The present study aimed to has explored attitudes and perceptions towards adopting the Korean MRCT guideline. Methods: An online survey, consisting of 16 questions, classified into two subjects, was administered to stakeholders in Korea. Most quantitative components were measured using the Likert scales. A content analysis of the qualitative components was carried out to identify the keywords in open-ended responses. Results: A total of 94 survey responses were analyzed: 51 participants from pharmaceutical companies, 11 from clinical research organizations, and 21 from clinical trial centers. The content of the guideline was rated as appropriate for clarity, acceptability, and applicability (96.8, 96.8, and 93.6%, respectively). The local environmental impact of the systemic/political, academic/technical, and industrial/economical aspects of the guideline was rated as appropriate at 95.7, 97.9, and 91.5%, respectively. The suggested adoption period was 1~2 years (40, 42.6%). The concept and individuals’ domestic circumstances were the key problems affecting the clarity, applicability, and local environmental impact of the guideline. Conclusion: The Korean MRCT guideline was well-developed. Their overall impact on the local environmental impact of MRCTs in Korea was expected to be beneficial, but methods are needed to minimize the negative impacts. The findings of this study can inform the priorities for the future adoption of the guideline in Korea.
목차
ABSTRACT
Methods
Survey design
Survey dissemination
Data analysis
Results
Participants
Contents of the multi-regional clinical trial guideline
Perspectives on adopting the guideline to Korea
Discussion
Conclusion
Acknowledgments
Declaration of conflicting interests
References
키워드
Multi-regional clinical trial global drug development regulatory science international conference on harmonisation guideline저자
간행물 정보
발행기관
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- 발행기관명
- 한국임상약학회 [Korean College of Clinical Pharmacy]
- 설립연도
- 1
- 분야
- 의약학>약학
- 소개
- 합리적 약물치료(rational pharmacotherapy)의 보장 및 증진을 궁극목적으로 하며 이를 달성하기 위해 임상약학의 발전과 회원 상호간의 친목을 도모한다.
간행물
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- 간행물명
- 한국임상약학회지 [Korean Journal of Clinical Pharmacy]
- 간기
- 계간
- pISSN
- 1226-6051
- 수록기간
- 1991~2026
- 등재여부
- KCI 등재
- 십진분류
- KDC 518 DDC 615
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