Multi-regional clinical trials and global drug development

Area of Science:

• Pharmaceutical Sciences
• Clinical Research
• Regulatory Affairs

Background:

• Globalized drug development necessitates multi-regional clinical trials (MRCTs) for timely regulatory submissions and improved patient access to novel therapeutics.
• Pharmaceutical companies increasingly conduct MRCTs to reduce market launch delays in key global regions.
• Despite benefits, sponsors encounter substantial challenges in executing MRCTs across diverse regulatory landscapes.

Purpose of the Study:

• To identify and discuss the multifaceted challenges encountered by sponsors during multi-regional clinical trials.
• To highlight the existing regulatory guidance from major authorities like the USA, EU-Japan, and China concerning MRCTs.
• To underscore the need for harmonization in MRCT design and planning to facilitate global drug development.

Main Methods:

• A review of challenges in multi-regional clinical trials, categorized into statistical, clinical, regulatory operational, and ethical domains.
• Analysis of existing regulatory guidance documents issued by key international regulatory bodies.
• Examination of the impact of non-harmonized MRCT approaches on drug development progression.

Main Results:

• Significant challenges exist in statistical, clinical, regulatory, and ethical aspects of conducting MRCTs.
• Disparate regulatory guidance across regions complicates MRCT planning and execution.
• Lack of harmonization in MRCT design and planning creates difficulties for sponsors, potentially hindering drug development.

Conclusions:

• Harmonization of MRCT guidance is crucial to overcome existing challenges and streamline global drug development.
• The International Council for Harmonisation (ICH) is working towards a harmonized guidance document for MRCTs, anticipated in early 2017.
• Addressing these challenges through harmonization will improve efficiency and patient access to innovative treatments worldwide.