Designing MRCTs with Different Regional Required Primary Endpoint
*Yi Tsong, FDA 

Keywords: MRCT, Regional Requirements

One of the challenges of a multi-regional drug development program is to design and analyze a multiple regional clinical trial (MRCT) with the objective of satisfying different regional requirements for the primary endpoint. Considering a MRCT designed to test for two primary endpoints, each for a separate region, data from a regularly well-controlled parallel arm trial may be used to test for two null hypotheses in terms of two distinct yet likely correlated endpoints. The two hypotheses may be tested sequentially or simultaneously. Depending on the structure of the hypotheses to be tested and the understanding of type I error rate control, various scenarios of type I error rate adjustments may be applied. Furthermore, for the objectives of getting approval from regional authorities using different primary endpoints, various sample size and power determinations may apply.