So what are the trends on overseas human subject trials?
An important one is that more and more clinical trials are being done outside the United States. Dr. Robert M. Califf, Vice Chancellor for Clinical Research at Duke University, told the Presidential Commission for the Study of Bioethical Issues, that a “massive shift” has occurred over the last decade.
Califf said that the United States was regarded by scientific researchers as a poor place to do trial because of higher costs and daunting bureaucracies. What are the positive attributes for the U.S. as host to clinical trials?
“It’s good at coordinating studies and telling people you have to do things,” he said. “It has an overly inflated view of itself.”
Cost alone is driving many of the scientific trials to countries such as India, China, Brazil, and South Africa, as well as developing nations. He cited one study in 2008 that found if a pharmaceutical company moved 50 percent of its trials from high-cost places and had 60,000 people in clinical trials, it would save $600 million a year.