Contract research organization (CRO) Parexel recently completed one of the first Chinese bridging studies to be conducted outside of China at the CRO’s Los Angeles facility. The study, conducted this spring, is one of a number of ethnobridging studies being pioneered by California Clinical Trials (CCT), which Parexel acquired two years ago.
When Waltham, Mass.-based Parexel acquired CCT, the CRO hoped to leverage CCT’s expertise in bridging studies. The company’s dedicated research unit in California provides access to large first generation Asian populations, and, with CCT’s help, Parexel has conducted more than 45 Japanese bridging studies and, now, one Chinese study.
“The goal of Parexel clinical pharmacology is to help sponsors to get as much information as soon as possible in drug development,” said Michelle Middle, corporate vice president and worldwide head of Clinical Pharmacology at Parexel.
Bridging studies, which compare a drug’s effect on different populations, have become increasingly important to clinical research, especially as pharmaceutical companies look to save time and development costs.
By conducting bridging studies outside of the region, sponsors eliminate some of the challenges they face with early phase studies within the Asia-Pacific region. It can take up to 12 months to get approval for conducting early studies in China, Middle said, as compared with one month in the United States.
“Obviously from a time perspective, it’s a much better option to do the studies in the States,” Middle said.
Although bridging studies in the United States may present fewer challenges, the process is far from easy. CROs and sponsors must recruit participants with specific traits. In the case of Parexel’s Chinese study, participants had to have Chinese parents and could not have been outside of China for more than two years.
“It’s pretty difficult for CROs to get involved in these studies because you do need native speakers—staff on board that includes nurses and doctors—that speak Japanese or Chinese. Many of the study participants don’t speak English, so that’s why it’s critical that staff be fluent in language,” Middle said. “For a CRO without experience, it would be pretty difficult to recruit for such a study.”
Parexel would not provide specifics about the amount of business the company is doing in the area of bridging studies, but, according to Middle, the CRO has several more Japanese studies in the pipeline and will conduct more Chinese studies upon request.
“We definitely expect a significant growth in specifically the Asian phase I studies, which include Japanese and Chinese bridging studies,” Middle said.
According to a recent CenterWatch report, the Asia-Pacific region is grabbing an increasing share of the global clinical trial market, and the market has grown more than 50% in recent years.
Parexel has also experienced an increase in activity in this region, largely stemming from the 2007 acquisition of Taiwan-based APEX International, which enabled the company to expand its research capabilities in Asia-Pacific. More than 1,000 Parexel employees are located in Asia-Pacific countries.