ABSTRACT
This chapter will discuss the key statistical considerations in sample size planning in multi-regional clinical trials (MRCT). It will build on the training module IV, discussing the concept of pooled region and pooled subgroups to aid overall sample size planning and allocation of that sample size across regions. This chapter will describe five approaches to sample size allocation as well as the pros and cons of each approach. In addition to the E17 sample size concept, we will also provide some summaries of popular statistical methodologies for sample size calculation and some practical implementation considerations.
