Clinical trials are increasingly moving offshore for a number of reasons (see: Status and Challenges of Offshore Clinical Trials). They include lower costs and the ready availability of "treatment-naive" subjects such that recruitment can be accomplished more easily than in the U.S. Moreover, it also easier to recruit subjects in poorer countries where they hope to obtain treatment that would otherwise not be available for them. A recent article provides some interesting insights into clinical trials in China (see: Drug makers seeking global guinea pigs). Below is an excerpt from it
For now, the world's emerging economies still play second fiddle to the United States when it comes to testing drugs. Clinicaltrials, a website run by the U.S. National Institutes of Health, currently lists more than 106,000 trials around the world, of which just over 50 percent are in the United States. But the balance is shifting, particularly when it comes to the big late-stage trials that really matter in deciding whether a drug is approved for sale. U.S. centers account for only 43 percent of the nearly 19,000 trials in final Phase III testing. As in so many other areas of life, the rising star is China, which already has a total of more than 2,700 clinical trials and is experiencing exponential growth....China has already leapfrogged the likes of Germany and France to become the world's third largest market for pharmaceuticals, and by 2015 it is set to overtake Japan as the second-biggest, behind only the United States, according to pharmaceutical market information company IMS Health....Independent expert Dr. Rory Collins, a professor of medicine at the University of Oxford and co-director of its Clinical Trial Service Unit, is a big fan of the power that Chinese clinical research can bring to medicine and is deeply impressed by how far the country has come in two decades....Six years ago, Collins's Oxford team led a huge 46,000-patient study in China -- the biggest ever seen in the country -- to test the blood thinner Plavix and a beta-blocker in the emergency treatment of heart attacks...."That study would never have been done if we couldn't have run this very streamlined trial in China at very low cost," says Collins, who is currently working on another pivotal heart drug study for Merck that contains no U.S. patients. "My preference would be not to do any trial in North America because it is so inefficient and so costly."
This article provided me with a new insight into the increased tempo of migration of clinical trials to China. As noted above, China is currently the world's third largest market for pharmaceuticals and by 2015 will become the second largest. Not only can clinical trials be performed for a lower cost in China but the market for pharmaceuticals in the country is also huge. One of the objections to clinical trials overseas for drugs that will be sold in the U.S. is that the research subjects are genetically different than the U.S. population. Here's an excerpt from an article that raises this issue (see: Clinical trials overseas raises quality control issues):
[Seth Glickman, M.D., a senior scholar at Duke's Fuqua School of Business] says social ecology and genetics may also play a role in trial outcomes, and may limit their applicability to patients who do not share such characteristics. For example, healthcare-rich economies produce patients with one set of characteristics, while participants with little access to healthcare may have quite different profiles. "It is conceivable that use of the same drug in both populations would produce markedly different results." Likewise, genetic polymorphisms, or "signatures" in some populations can affect response to certain drugs, making it inappropriate to apply results from studies in these populations to patients who do not share those characteristics.
With regard to clinical trials in China, and perhaps India, the pharmaceutical companies derive benefit in two ways. First, they can manage their clinical trials more efficiently and less expensively. Secondly, the "genetic signatures" of the subjects in the trials would be close to that of the patients in China for whom the drugs would eventually be prescribed.
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