Clinical drug trials are going global as big pharma seeks to further cut costs while also accumulating “treatment-naïve” patients who may be more suitable for testing new drugs. In an article for Reuters, Ben Hirschler discusses the pros and cons of outsourcing clinical trials to countries such as Poland, where the number of patients involved in trials has risen fivefold between 2005 and 2009. In Hungary, that number went up three-and-a-half times during the same period.
These days, 4 out of 5 of all subjects enrolled in trials supporting applications submitted to the FDA were recruited from foreign sites, as the drug industry is focusing more heavily on the prospects of emerging markets abroad. But the new move has some downsides, too, like concerns over ethical standards, safety and the quality of data obtained. For instance, in the PLATO trial for AstraZeneca’s new anti-platelet drug Brilinta, less than 10 percent of the 18,000 patients were North American — a group considered too small to draw any statistically significant conclusions from, which is why the FDA is requesting more data before it can approve the drug in the U.S.
But for pharmaceutical companies, the move to expand clinical trials outside of the U.S. has many perks. Not only does it save them money, but it allows them to escape the stringent policies surrounding trial procedures at home.
Dr. Michael Crawford, professor of medicine and chief of clinical cardiology at the University of California, San Francisco, acknowledges that many of his colleagues have abandoned clinical research because “it’s just too difficult and the expenses are so high you end up being in the red when you do a study.”
ACSH's Dr. Gilbert Ross agrees that the requirements for clinical trials in the U.S. are onerous. “It’s getting even harder to conduct large trials and will become much more so when comparative efficacy data are required. Running trials in foreign lands is less expensive, although we still have to be cautious about the lack of oversight in other nations and especially about informed consent. Though some ethical issues may arise, we shouldn’t automatically deny African or Asian people the opportunity to participate in clinical trials, thus denying them access to newer and cheaper drugs.”