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Many Clinical Trials Moving Overseas
Date:2/18/2009

India may cost less than one-tenth per patient what it would cost at a second-tier U.S. center); faster approval times; and less red tape.

"One reason the industry is going abroad is the fact that there are complicated regulations [in the U.S.] discouraging pharmaceutical companies, although the main driving force is cost," said Adil Shamoo, a biochemistry and bioethics professor at the University of Maryland at Baltimore and editor-in-chief of Accountability in Research.

But what happens to the rights of human subjects, and to the types of drugs being developed?

"Are their rights being protected? Are they being given unfair financial inducements to participate?" Schulman asked. "That's very hard to govern and regulate and even to understand."

"The public and potential volunteers in the U.S. are more aware of their rights in the U.S. than in populations elsewhere," added Shamoo. "If we have a hard time reporting adverse events in this country, can you imagine how that would be in poor countries?"

Another consideration is whether drugs approved via trials overseas would actually be available at a reasonable cost in those countries.

And whether overseas trials even test drugs that are needed in those countries is also a question, the study authors said, citing, for example, that drugs for overactive bladder and fibromyalgia are being developed in countries where diseases like malaria and tuberculosis are prevalent.

"There's a huge benefit to research being conducted in the U.S.," Schulman said. "At a national level, we need to understand which therapies Medicare should pay for and which are effective in a Medicare [older] population, and we can only answer those questions if we do the research here."

Reacting to the report, FDA spokeswoman Karen Riley said the agency weighs in on clinical trials in many venues, and "is doing a number of things to enhance foreign oversight."


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