MRCT

MRCT stands for Multi-Regional Clinical Trial, a type of clinical study conducted across multiple geographic regions to evaluate a medical product. The goal is to generate safety and efficacy data that are broadly applicable to diverse patient populations and to support regulatory submissions in several jurisdictions through a single program.

Regulatory context and rationale: MRCTs are used in global drug development to streamline submissions and better reflect real-world, multinational use. They are aligned with International Council for Harmonisation (ICH) guidelines, including ICH E5, which addresses the use of foreign clinical data and ethnic factors, and ICH E17, which focuses on designing and interpreting global development plans. While MRCTs can reduce duplication and shorten time to market, region-specific bridging studies or analyses may still be required if notable ethnic or pharmacogenomic differences are suspected.

Design and methodological considerations: Effective MRCTs strive for representative participation from multiple regions, standardized protocols, harmonized endpoints, and centralized data collection. Prespecified analyses typically assess overall treatment effects and potential heterogeneity by region, ethnicity, or demographics. Operational considerations include regulatory alignment, ethical approvals, site qualification, and rigorous quality control to ensure consistency across regions.

Limitations and impact: MRCTs introduce greater complexity and higher operational costs and can present interpretive challenges if regional differences are substantial. Nevertheless, they remain a central approach in global regulatory strategy, aiming to produce generalizable evidence for multiple markets and to improve efficiency in global drug development.

Further context: The Multi-Regional Clinical Trials Center (MRCT Center) at Brigham and Women’s Hospital and Harvard Medical School conducts research on global trial design and regulatory science, reflecting ongoing efforts to improve the governance and success of MRCTs.