As many American companies in the last decade have sent tasks like customer service and computer support to other countries, drug makers have followed suit by outsourcing clinical trials — the human studies that determine the safety and efficacy of medicines.
Now, an article about the globalization of clinical trials, published Thursday in The New England Journal of Medicine raises questions about the ethics and the science of increasingly conducting studies outside the United States — when the studies are meant to gather evidence for new drugs to gain approval in this country.
The article, by several Duke University researchers, suggests an ethical quagmire when drugs intended for wealthy nations are tested on people in developing countries. The authors suggest that human volunteers in foreign countries may be unduly influenced with the promise of financial compensation or free medical care to participate in clinical trials.
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