Why are drugmakers racing overseas? There are several reasons. For one, running clinical trials in many other countries can be cheaper than in the U.S. Finding the necessary number of enrollees can also be easier in countries where health care is inadequate, which makes trials an attractive alternative. There’s also the opportunity to gain a toehold in expanding markets, where regulatory barriers may be fewer.

With all this activity, problems can occur. Last year, Wyeth briefly halted a vaccine trial in India while authorities probed the death of an infant with a preexisting condition, which should have disqualified the child. Ultimately, the drugmaker was exonerated. And GlaxoSmithKline was criticized for allegedly using children from poor families in Argentina who may not have fully understood consent forms for a vaccine trial. Glaxo denied the charges and insisted it complied with international standards.

Nonetheless, drugmakers and the companies they hire to run clinical trials—which are known as clinical research organizations—insist they go to great lengths to establish proper protocols, carefully oversee trial sites, and work with local authorities to ensure patients receive proper treatment. In fact, the Association of Clinical Research Organizations, an industry trade group, has been so concerned about the issue that it commissioned a white paper, which was released over the summer.

In the paper, ACRO maintained that most early-stage trials, which involve safety testing in humans, continue to be run in just three well-developed countries, including the U.S. And most industry research and development spending—96 percent —took place in developed countries during 2007. They also argue that there are benefits to overseas trials, namely speeding drug development and improving foreign health care systems.

“On a flattened earth, with waning U.S. participation in clinical trials, global trials are helping speed important drugs to market,” says Doug Peddicord, ACRO’s executive director, in a statement. The group goes on to say that the advantages of going overseas sometimes bring “rare but well-publicized lapses in standards.”

So how should the problem be addressed? There seems to be agreement among critics and industry players on this much—find the best ways to ensure all clinical-trial participants adhere to international standards and make it possible for the Food and Drug Administration to conduct inspections around the world. Says Sharav: “There has to got to be more oversight.”