The globalization of clinical research is raising a number of troubling ethical and scientific concerns, according to a new article by Duke researchers in the New England Journal of Medicine. The problems discussed in the article include patient selection, transparency of results, regulatory oversight, experience of clinical investigators, and IRB quality. Coauthors of the paper include well-known Duke cardiologists Eric Peterson, Robert Harrington, and Robert Califf.
But not everyone shares the concerns of the Duke authors, and some researchers question the methodology used in the paper, according to an article in the New York Times by Natasha Singer. The article quotes the chairman of bioethics at the Clinical Center of the NIH, Dr. Ezekiel J. Emanuel, who cites a clinical trial of Gardasil in Costa Rica, where human papilloma virus is widely prevalent. “This is the kind of case where it is a good thing,” said Emanuel.
The FDA response to some of these issues is discussed in an article in the Wall Street Journal by Shirley Wang.
In the Wall Street Journal Health Blog, Shirley Wang asks a number of experts how clinical trials can be lured back to the US. One idea:
A more centralized clinical trials approval process and efficient use of regulatory resources could streamline it in this country, study author Charles Cairns of UNC-Chapel Hill, told the Health Blog.
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