다지역 임상시험의 계획 및 설계에 대한 국제 제도적 동향 분석

Abstract

Objective: Multi-regional clinical trials have been widely used for accelerating global drug development by multinationalpharmaceutical companies. In this study, we aimed to review and analyze the international trends in regulations and guidelines onmulti-regional clinical trials by regulatory authorities and international organizations, such as International Conference onHarmonisation, for referring to policies, including development of domestic guidelines for multi-regional clinical trials. Methods: Thepolicies, 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 theInternational Conference on Harmonisation E17 draft guideline was reviewed. Results: The regulatory authorities in developedcountries have developed and implemented regulations and guidelines on multi-regional clinical trials to promote simultaneousglobal drug development and evaluate the regional differences in drug safety and efficacy. International Conference onHarmonisation developed the draft guideline for planning/designing of multi-regional clinical trials in 2016, which recommends thegeneral principles for strategy-related issues and design of multi-regional clinical trials, and for protocol-related issues, such asconsideration of regional variability, subject selection, dose selection, endpoints, comparators, overall sample size, allocation toregions, collecting information on efficacy and safety, and statistical analysis. Conclusion: It is important to understand theinternational 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 trialsand drug administration.