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Abstract:
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Compared to a multi-center trial conducted in many medical centers in one country, or to a multi-national trial in many countries in similar regions (e.g., developed world such as West Europe and North America), a multi-regional clinical trial (MRCT) represents tremendous opportunities but also greater challenges. Recent research effort and collaboration to address these challenges have led to better understanding of these issues. However, it probably is too early and too optimistic to claim that all stakeholders' views have converged. In fact, different stakeholders (such as academia, industry or other sponsors, and health authorities in developed/developing regions/countries) have different expectations, objectives and concerns for MRCTs. These different views lead to different assumptions, focus, and proposed methods to address the issues. In this talk, we will identify these different views that drive the divergence of proposed statistical methods. Examples will be used to illustrate the key points. We hope this work can help stakeholders to better understand the root cause of differences and facilitate convergence/harmonization that leads to improved practices.
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