Asian clinical trials for new drug approval

Abstract

One third of all industry sponsored phase III drug trial registered in the US trial registry are carried out in Asian. It significantly exceeded the proportion of non-industry sponsored drug trial in this area. With the driving force of the globalization, economic shift from the west to the east, relative the lack of investigators, patients etc. in established regions, Asia have nourished to become one of the most important global regions for drug trials. It is noted that the North East Asia represents more than two third of all industry-sponsored trial sites in Asia, in which most of them are phase II/III. It is predicted to become the most popular emerging clinical trial region in the coming years. In this presentation, some basic concepts of drug clinical trials will be elaborated. The current status of Asian drug clinical trials will also be discussed and analyzed. Hopefully this could provide some update on the recent situation and a more in-depth understanding to our own position in this aspect.