US-based contract research organisation (CRO) Parexel International is expanding its capabilities in ethnobridging studies designed to expedite early-phase drug development in both Asia and the Western Hemisphere.

The CRO has just completed a Chinese ethnobridging trial in the US, saying it is one of the first companies to do so outside China. The Phase I study was carried out by Parexel’s California Clinical Trials (CCT) unit in Los Angeles, which has access to large first-generation Asian populations including 500,000 Chinese, 600,000 Koreans and 40,000 Japanese. The CRO has also completed ethnobridging studies in Korean and Japanese populations.

Asian bridging trials are conducted in early clinical development to help biopharmaceutical companies gather relevant ethnic data in the US. These companies may face challenges when pursuing early-stage trials in certain Asia-Pacific countries such as China, Parexel notes. The ethnobridging trial is a pharmacokinetic study to determine drug safety and tolerability as well as possible pharmacokinetic differences in a target ethnic population.

Phase I data collected in the US can then be used for global trials that include China or for registration in China, saving time and development costs, the CRO adds. They also give clients options for parallel development programmes in Western and Asia-Pacific territories.

Parexel stepped up its capabilities in International Conference on Harmonisation (ICH) bridging and ethnic sensitivity studies by acquiring CCT in 2006. This included Japanese studies: to date, the CRO has completed more than 40 Japanese bridging trials and says it has the largest database of qualified volunteers outside Japan.

Now Parexel is building further on these foundations to meet growing client demand for global development programmes that take in the Asia Pacific region. The move reflects projections that Japan will maintain its standing as the second largest pharmaceutical market worldwide while China is positioned to become the sixth largest market by 2010.