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논문검색

Original Article

다지역 임상시험의 계획 및 설계에 대한 국제 제도적 동향 분석

원문정보

Regulations and Guidelines for Planning and Design of Multi-regional Clinical Trials

송윤경, 손민지, 전아영, 김재현, 지은희, 오정미, 김인화

피인용수 : 0(자료제공 : 네이버학술정보)

초록

영어

Objective: Multi-regional clinical trials have been widely used for accelerating global drug development by multinational pharmaceutical companies. In this study, we aimed to review and analyze the international trends in regulations and guidelines on multi-regional clinical trials by regulatory authorities and international organizations, such as International Conference on Harmonisation, for referring to policies, including development of domestic guidelines for multi-regional clinical trials. Methods: The policies, regulations, and guidelines published by the US Food and Drug Administration, European Medicines Agency, Pharmaceuticals and Medical Devices Agency (Japan), and China Food and Drug Administration were searched, and the International Conference on Harmonisation E17 draft guideline was reviewed. Results: The regulatory authorities in developed countries have developed and implemented regulations and guidelines on multi-regional clinical trials to promote simultaneous global drug development and evaluate the regional differences in drug safety and efficacy. International Conference on Harmonisation developed the draft guideline for planning/designing of multi-regional clinical trials in 2016, which recommends the general principles for strategy-related issues and design of multi-regional clinical trials, and for protocol-related issues, such as consideration of regional variability, subject selection, dose selection, endpoints, comparators, overall sample size, allocation to regions, collecting information on efficacy and safety, and statistical analysis. Conclusion: It is important to understand the international regulatory requirements for designing and planning of multi-regional clinical trials for global drug development. Moreover, it is necessary to prepare multi-regional clinical trial guidelines in accordance with the Korean regulation for clinical trials and drug administration.

목차

ABSTRACT
 연구 방법
 연구 결과
  미국 FDA
  유럽 EMA
  일본 MHLW 및 PMDA
  중국 CFDA
  ICH
 고찰 및 결론
 감사의 말씀
 참고문헌

저자정보

  • 송윤경 Yun-Kyoung Song. 서울대학교 약학대학, 종합약학연구소, 대구가톨릭대학교 약학대학
  • 손민지 Minji Sohn. 서울대학교 약학대학, 종합약학연구소
  • 전아영 Ah Young Jeon. 서울대학교 약학대학, 종합약학연구소, 서울대학교병원, 약제부
  • 김재현 Jae Hyun Kim. 서울대학교 약학대학, 종합약학연구소
  • 지은희 Eunhee Ji. 가천대학교 약학대학
  • 오정미 Jung Mi Oh. 서울대학교 약학대학, 종합약학연구소
  • 김인화 In-Wha Kim. 서울대학교 약학대학, 종합약학연구소

참고문헌

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