New Guide Helps Sponsors Compare Asia-Pacific Countries for Medical Device Trials

Tue, 10/08/2013 - 8:00am
The Associated Press

A new booklet from Theorem Clinical Research is now available to help researchers at medical device companies decide if they want to conduct clinical trials in the Asia-Pacific region, and, if so, in what countries. Titled “ A Guide to Country Selection in the Asia-Pacific for Medical Device Trials,” the new booklet compares the pros and cons of conducting trials in different areas of the region including China, Japan, South Korea, Philippines, Taiwan, Singapore, Malaysia, Thailand and Australia/New Zealand.

“Estimates show that by 2015, more than 50 percent of growth in global clinical trials will be directly attributed to the offshoring of clinical trials to emerging markets,” said D. Lee Spurgin Jr., PhD, one of the booklet’s authors. “The challenge for sponsors is to understand why they may want to go to Asia.” Spurgin said there are many reasons the Asia-Pacific region is desirable for clinical studies. Outsourcing in Asia can reduce the cost of trials by more than 50 percent; generally, less complicated regulatory regimes mean faster approval timelines. Downsides vary and range from language and cultural difficulties to differences in regulatory procedures for medical devices.

In addition to Spurgin, senior vice president and general manager of medical device and diagnostic development for Theorem Clinical Research, the booklet’s co-authors include Laura Lin, MD, director of clinical operations, and Jeremy Xie, MS, account director. Both have significant experience in Asia relevant to the topic.

“A Guide to Country Selection in the Asia-Pacific for Medical Device Trials” is available for $6.99 through Amazon.



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