American Medical News examines clinical trials outsourcing

American Medical News examines the ethical considerations of outsourcing pharmaceutical clinical trials to developing countries. The article highlights how it is less expensive for a drug company to conduct a trial in India, where it runs about $2,000 to track a patient through a trial, compared to the cost in the U.S., which is "10 times more." The disparities between participants in the two countries in terms of income, education and access to care are "stark" and the playing field "uneven," writes American Medical News.

While twenty years ago, most U.S. companies conducted clinical trials on their home soil, now "[t]he 20 largest U.S.-based drugmakers conduct about a third of their phase III clinical trials outside the country, and a majority of their study sites also are elsewhere, says a Feb. 19 article in The New England Journal of Medicine," according to American Medical News.

"There are just going to be more people in other parts of the world who are having health issues that need to be addressed and are ready to consent to clinical trials, because really it is the only mechanism for receiving care," said Jill Fisher of Vanderbilt University's Center for Biomedical Ethics and Society. She added that "clinical trials are a problematic kind of care, because it comes in the context of a study intervention. But people are ready to enroll, because they see it as such an incredible advantage over basically nothing."

The article outlines additional concerns about outsourcing clinical trials, such as limited ethical oversight of trials, language barriers, cultural norms and government corruption, as well as comments by other experts on the pros and cons of clinical-trial outsourcing (O'Reilly, 9/7).