It's not just pharma sales that are going global. Recent events highlight how clinical research is also moving from established, mostly Western countries to emerging markets.
Yesterday's news that Charles River Labs is buying its Chinese competitor WuXi took a lot of people by surprise. In discussing the transaction, Bloomberg reports that the Chinese market for contract research is growing as much as 30% annually - more than 3 times as fast as the global growth rate.
What's causing this explosive growth in China and in other emerging markets? The drivers appear to be lower costs, easier access to patients, and fewer hassles.
Conducting a clinical trial in China can be 50% cheaper than a comparative trial in a Western country. Lower labor costs and site fees add up quickly.
With significantly fewer sites competing for patient populations, CROs and sponsors find that patient recruitment in China is easier, allowing research sites to produce more patients than sites in traditional regions.
The "fewer hassles" factor comes in two flavors. First, in the U.S. and Europe, animal-rights activists regularly harass drug makers and researchers and don't shy away from aggressive tactics. It's kind of hard to imagine this happening in China...
Second, the "red tape gap" is widening between China and Western countries. CBC quotes the editor in chief of the Canadian Medical Association Journal as follows:
"[In Canada and other countries,] regulations have grown so burdensome that they are overwhelming the very things they are meant to support and safeguard. Consequently, clinical research has been substantially decreased among industrialized countries."A professor who's also quoted in the same piece makes it even more black-and-white:
"Ten or 15 years back, you have [a] one- or two-page consent ... Now it's a 14-, 15-page consent. And imagine a patient coming in with a heart attack and you're trying to test a potentially useful new drug. To give them a 14-page consent is just, it's meaningless."No such worries exist in China: According to a 2009 article in the New England Journal of Medicine, 90% of published clinical trials conducted in China in 2004 did not report ethical review of the protocol and only 18% adequately discussed informed consent.
And this is the pickle that drug developers find themselves in: How much patient protection is enough, and are the savings worth reduced quality control and compliance in China?
Stay tuned... We are sure to find out the answers in the years to come.
ForeignExchange provides specialized medical translations for clinical trial applications, protocols, informed consents, patient diaries, INDs, patient recruitment, and health economic research - in Chinese and dozens of other languages. Contact us for more information about our clinical translation services.