Korean J Clin Pharm.  2018 Jun;28(2):146-153. 10.24304/kjcp.2018.28.2.146.

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

• Song YK
• Sohn M
• Jeon AY
• Kim JH
• Ji E
• Oh JM
• Kim IW

• KMID: 2416674
• DOI: http://doi.org/10.24304/kjcp.2018.28.2.146

Abstract

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.

Keyword

Multi-regional clinical trials; global drug development; guideline; regulation

MeSH Terms

China
Developed Countries
Sample Size
Social Control, Formal*
United States Food and Drug Administration