Bridging Studies- A Key in the Extrapolation of Clinical Results between Regions

摘要

In pharmaceutical industry, the sponsors are interested in bringing their drug products from one region (e.g., the United States of America) to another region (e.g., Asian Pacific) to increase the exclusivity of the drug products in the marketplace. However, it is about the clinical results that can be extended from the victim patient population in one region to a similar, but different patient population in a new region due to a possible difference in ethnic factors. The International Conference on Harmonization (ICH) suggested that a bridging study may be important to extrapolate the clinical results between regions. However, little or no information concerns the basis for determining whether a bridging study is necessary based on the assessment of the complete clinical data package provided by the ICH. Moreover no criteria on the evaluation of similarity of clinical results between regions is given.