ABSTRACT
The implementation of a global drug development strategy is a challenging, timeconsuming, and expensive process. To gain approval to market a drug, sponsors are required to provide rigorous evidence of efficacy and safety using data from large multicenter, randomized, controlled clinical trials. In the United States (US), for example, the Food and Drug Administration (FDA) requires that at least two clinical studies in the same targeted patient population be performed to confirm the reproducibility of the evidence demonstrating efficacy, safety, and dose-response of the investigational agent. Data used to obtain regulatory approval in one region (e.g., the US), however, often prove insufficient to obtain approval in another region (e.g., Japan), thereby necessitating the further collection of clinical trial data in the new region of interest. Such duplication of previously collected registrational clinical trial data not only requires additional resources, but may also result in a significant delay in bringing the drug to market in the new region.
