Sample Size Allocation for Multi-Regional Clinical Trials

Free Webinar:

Selecting Appropriate Regional Proportions

A multi-regional clinical trial (MRCT) is a clinical trial conducted in more than one region under a common protocol. Traditionally, drug development occurred in a single jurisdiction, and expanding to other regions required bridging studies to ensure consistent efficacy and safety. This often resulted in delays before new therapies reached patients.

MRCTs are now increasingly used to improve efficiency, reduce redundant trials, and accelerate regulatory approvals worldwide. Regulators, including Japan’s PMDA, have provided guidance on patient allocation for sub-regions, including two recommended methods.

In this webinar, Denis Desmond, Research Statistician at nQuery, will explore sample size allocation in MRCTs, bridging studies, and regulatory guidance, with practical demonstrations in nQuery.

Learning objectives:

In this webinar, you will learn how to navigate the complexities of multi-regional clinical trials, empowering you to optimize sample size allocation, meet regulatory guidance, and conduct efficient, globally aligned studies.

Key Areas Covered:

1. Understand Multi-Regional Clinical Trials (MRCTs)

• Define MRCTs and their role in global drug development

• Recognize the differences between single-region trials and MRCTs

• Understand the challenges and opportunities of conducting MRCTs

2. Design Considerations for MRCTs

• Learn how to plan trials that satisfy regulatory requirements across regions

• Identify criteria for patient allocation in sub-regions

• Understand strategies to optimize trial efficiency while maintaining scientific rigor

3. Bridging Studies and Regulatory Guidance

• Understand the historical role of bridging studies

• Explore PMDA guidance and two proposed methods for regional sample allocation

• Recognize how regulatory guidance can inform trial design

4. Practical Sample Size Determination in nQuery

• Apply PMDA Methods 1 & 2 to real-world examples

• Demonstrate how to allocate patients appropriately across regions

• Use nQuery for accurate, reproducible sample size calculations

About nQuery

nQuery helps make your clinical trials faster, less costly and more successful. So if you need something more than just a sample size calculator, nQuery is an end-to-end platform covering Frequentist, Bayesian, and Adaptive designs with 1000+ sample size procedures. 

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