Updated: 7:50 p.m.
CINCINNATI, Ohio — The clinical research company Kendle has added locations in the capital cities of Malaysia, Philippines and Thailand — betting with the rest of the industry that more medical trials will take place outside of the United States and in Asia in particular.
Kendle stated that its new operations in Kuala Lumpur, Manila and Bangkok will expand its competitive edge in the region. A majority of all clinical trials are done overseas, according to a study published in February in the New England Journal of Medicine. Kendle cited Tufts Center for the Study of Drug Development research stating up to 65 percent of FDA-regulated clinical trials will, in the next three years, be conducted outside the United States with many moving to Asia.
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Kendle, based in Cincinnati, has operated in Asia since 1998 and already has a total of eight offices in China, India, Singapore and Australia. The company is able to perform all phases of clinical trials throughout the globe, though it performance Phases II through IV in Asia, according to the company.
Malaysia, Philippines and Thailand have created “favorable environments for global clinical development work,” mainly through making biopharmaceutical development a key sector in their economies, according to Dr. Ross Horsburgh, Kendle’s vice president for Global Clinical Development – Asia/Pacific.
But expanding into economically depressed areas like Southeast Asia keep Kendle squarely in the midst of the ethical debate of overseas trials. A $2,000 clinical trial at a top Indian research institution is 10 times less than the cost here, there is no uniform approach to clinical trials, and genetic differences may alter findings done in Asia versus the United States, according to the New England Journal of Medicine report.
Plus ethicists have been unhappy with recent changes by the U.S. Food and Drug Administration to address overseas trials, according to a report in The Wall Street Journal.
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