Asia Becoming Important Phase I Player (Asia)
This article was originally published in PharmAsia News
Executive Summary
Global pharmaceutical companies are increasingly conducting clinical trial development from the basics upward in Asia, rather than simply using Asia's outsourcing industry for late-stage clinical work. As a result phase-I clinical trials are becoming more prevalent in China, South Korea, Japan, and India, alongside late-stage trials more often underway in these developing countries. Shirley Suresh of Singapore Clinical Research says that comparing global data from full-spectrum clinical trials is more scientifically effective than comparing data from "bridging studies." The U.S.-based FDA concurs, notes Suresh. Suresh says that Singapore has been encouraging companies to develop research from the phase-I level, and has been attracting international attention. Singapore also has a mixed Asia population, and so its clinical trial data is being accepted in South Korea, in some cases in Japan, and by other countries, says Suresh. Japan's recent lowering of regulatory hurdles to clinical trials should boost the volume of global companies conducting clinical research in Japan in 2008 and 2009. (Click here for more