Aims
This study aimed to identify population/regional differences in drug efficacy and the influencing factors among East Asians to be considered when planning multi‐regional clinical trials (MRCTs) to facilitate rapid drug approval in Asians.
Methods
A retrospective analysis of efficacy (intergroup difference in endpoint between control and study drug treatment) among East Asian populations for three drug categories, antidiabetic, respiratory, and psychotropic agents, was conducted in collaboration with pharmaceutical companies using their MRCT data. Common endpoints by drug category were selected; background factors that commonly affected the endpoints among regions were analysed first; then, the population/regional differences were evaluated by the interaction term "region‐by‐treatment" using an analysis of covariance model after adjusting for background factors.
Results
Among 17 endpoints for eight pharmaceutical products from three drug categories, no substantial population/regional differences were detected in the three drug categories examined (p>0.05), except for HbA1c change between Japan and Korea for an antidiabetic drug, insulin glulisine (p=0.0068). However, no such regional differences were evident in patients with clinically important higher HbA1c baseline values (majority subgroup). Variability in disease severity at baseline and concomitant drugs were determined to be potential influencing factors for regional differences.
Conclusions
This study suggests that the regional variability in efficacy of these three drug categories is not large among East Asians, and reveals the importance of considering background factors when planning MRCTs. Further studies are needed to evaluate regional variability in the efficacy of other drug categories and clarify the factors leading to regional differences in East Asians.
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