Implication of Asian Studies in Simultaneous Global Clinical Trials
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*Masahiro Takeuchi, Kitasato University, Japan 


A growing number of global trials are now performed in emerging regions such as Asia, where the costs are substantially lower than in ICH regions. Conducting global clinical trials with one common protocol has become increasingly accepted for new drug approval applications, yet these trials do not necessarily take regional differences into account. For example, evidence has suggested that dose adjustments and other considerations are necessary to account for ethnicity and other intrinsic factors. We will discuss issues regarding the role of Asian studies and strategies focusing on adequate patient population, drug dosage, and treatment response using surrogate markers and adaptive design. We will share examples from gastric cancer, dilated cardiomyopathy and chronic obstructive pulmonary disease.