'Trial Design Issues and Treatment Effect Modeling in Multi-Regional Schizophrenia Trials
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*Yeh-Fong Chen, FDA 

Keywords: Multi-Regional Clinical Trials

In recent years, an increasing number of new drug applications (NDAs) containing foreign trial data have been submitted to the U.S. Food and Drug Administration (FDA). The wealth of data on schizophrenia trials in the FDA archived database presents an opportunity to study design and analysis related issues of multi-regional clinical trials. Based on 33 schizophrenia trial data where 63.8% of the patients were from North America, two main aspects will be covered in this talk. First, the investigation into some of the study design issues will be illustrated including potential heterogeneity of treatment effect via meta-analysis and placebo response pattern over time. Second, the results of empirical modeling by two methods (i.e., supervised and unsupervised) will be shown so as to explain the potential impact of baseline covariates on the treatment effect in multi-regional clinical trials.