Many Clinical Trials Moving Overseas

Study says trend raises ethical, medical issues

By Amanda Gardner
HealthDay Reporter

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WEDNESDAY, Feb. 18 (HealthDay News) -- A new report contends many clinical drug trials are now being run outside the United States and in far reaches of the globe, and that the trend raises troubling ethical and medical issues.

The implications of this, according to Dr. Kevin A. Schulman, senior study author, are that drugs are being tested on people who may not align with the types of patients in the United States who would ultimately use the drug.

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"At the end of the day" with such a scenario, added Schulman, a professor of medicine and business administration at Duke University, in Durham, N.C., "would [the potential drug] work the same way here? We may not know the answer to that question."

Dr. Robert M. Califf, a Duke University medical professor who is rumored to be one of President Barack Obama's candidates to head the U.S. Food and Drug Administration, which oversees clinical trials in the United States, was a co-author of the research. Their report appears in the Feb. 19 issue of the New England Journal of Medicine.

Their review of a U.S. government clinical trials registry and of 300 published reports in major medical journals revealed this: A third (157 of 509) of Phase 3 trials -- typically the largest and most significant trial in the development of a drug -- led by major U.S. pharmaceutical companies were being conducted entirely outside the United States. In addition, half of the study sites (13,521 of 24,206) used in these trials were located overseas, with many in Eastern Europe and Asia.

At the same time, the researchers found, the number of FDA-regulated investigators running trials abroad has increased by 15 percent each year, while the number of U.S.-based investigators declined 5.5 percent annually.

Several forces are pushing trials elsewhere, the researchers noted: cost (a trial at a top medical center in 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.

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