Evaluation of Data for Multi-Regional Trials: A Three-Layer Approach

Applied Clinical Trials Online: Nov 1, 2013

In the three-layer approach proposed in this article, how to interpret data in multi-regional trials into three layers is explored: Layer 1 to first look at overall study results, Layer 2 to identify factors which influence overall results from scientific and regulatory perspectives, and Layer 3 to discuss benefit/risk for a specific country/region.

 

Multi-regional trials data collection

The International Conference on Harmonization’s (ICH) ”E5 Guideline on Ethnic Factors in the Acceptability of Foreign Clinical Data” (ICH-E5) (R1) was introduced in March 1998.1 Since the ICH-E5 guideline was issued, there has been a lot of discussion on the importance of evaluating the impact of ethnic factors on the ability to extrapolate efficacy and safety data to a new region in order to minimize duplication of clinical trials. Moreover, in recent years, a shift in clinical trials to so-called emerging regions, especially in Eastern European, Latin American, and Asian countries has been noted. This contrasts with traditional clinical trials which have been carried out in relatively affluent countries in North America, Western Europe, and Oceania.2 In other words, in recent years, drug development has become dramatically globalized, and multi-regional trials (MRTs) are now being extensively conducted in both ICH and non-ICH regions. Read more