Top-tier U.S.-based pharmaceutical companies are moving their clinical trials overseas at warp speed, raising questions about ethics, quality control, and even the scientific value of their findings for people back in the U.S.
Many of the trials are taking place in developing countries in Eastern Europe and Asia where study participants are often poorer and less educated than are study participants in the U.S., according to researchers at Duke Clinical Research Institute (DCRI).
"The FDA is supposed to provide oversight for such trials, but it simply wasn't designed to handle this kind of situation," says Kevin Schulman, M.D., the senior author of the report appearing in the New England Journal of Medicine . Schulman says the number of Food and Drug Administration investigators based outside the U.S. has grown by 15 percent every year since 2002, while the number of U.S.-based investigators has fallen just over 5 percent during the same period.
Schulman and a research team led by Seth Glickman, M.D., a senior scholar at Duke's Fuqua School of Business, used the clinicaltrials.gov registry to examine recruitment patterns in industry-sponsored Phase 3 trials in 2007. Phase 3 trials are typically the largest and most meaningful trials, often involving thousands of patients. They found that about a third of the trials (157 of 509) were being solely conducted outside the U.S. They also discovered that over half the study sites (13,521 of 24,206) lay outside U.S. borders.
Researchers also reviewed 300 articles reporting clinical trial results appearing in the New England Journal of Medicine , the Journal of the American Medical Association and the Lancet in 1995 and 2005 and found that over that decade, the number of clinical trial sites abroad doubled, while the number in the U.S and Western Europe declined.
"There are powerful forces luring clinical trials overseas, including the lower cost of doing business and access to larger study populations," says Glickman. "The cost per participant in a clinical trial in India, for example, can be only one-tenth of what it is in the U.S."
"But there are equally powerful forces pushing," says Schulman, who adds that a mix of well-intentioned policy efforts is actually creating barriers to conducting research in a timely fashion in the U.S.
The authors say some of the clinical trials abroad are raising concern about aligning research to the health needs of the population under study. "It's pretty clear that companies are testing drugs in countries where they will not be marketed or sold," says Glickman. "This is a major ethical concern." The researchers found plenty of examples where companies were testing drugs for conditions such as allergic rhinitis, fibromyalgia and overactive bladders in emerging markets – rather than treatments for diseases like malaria or tuberculosis that might be more prevalent there.