Are overseas trials generating suspect data on new drugs?

One of the biggest trends in drug development in recent years has been the push to conduct more clinical trials overseas in order to cut costs, garner more data and penetrate new markets. Now Reuters top biotech reporter Ben Hirschler has taken an in-depth look at the economic and market drivers pushing developers to recruit more and more of the patients they need for clinical trials in Eastern Europe, Asia and Latin America. And he highlights a growing debate among drug researchers over the quality of the data these overseas trials produce and the supposed cost savings developers had hoped to achieve.

Exhibit A: AstraZeneca's crucial pivotal trial of Brilinta has come under scrutiny as experts questioned data indicating that Americans did worse than the other nationalities represented in the trial. With Americans accounting for slightly less than 10 percent of the trial subjects, though, regulators and researchers have struggled to explain the data and its implications for the drug's effectiveness in the world's biggest pharma market. And Dr. Magnus Ohman and Dr. Matthew Roe of Duke University Medical Center concluded that the PLATO results "should serve as a warning to all stakeholders in global cardiovascular research that balanced enrollment around the world in pivotal trials should be the goal for any future drug development program."

Some doctors, like UCSF's Michael Crawford, have concluded that any data that comes from an overseas trial is suspect. "I don't have any way of assessing the quality of research in an Eastern European country," he tells Reuters. "It may be wonderful, but I don't have any way of assessing that. I know if a study is conducted in the United States and Canada, it's done according to certain standards."

Oxford's Dr. Rory Collins, though, says that lower cost overseas trials give researchers a big advantage. "My preference would be not to do any trial in North America because it is so inefficient and so costly."

There are some compelling reasons to conduct a study in an emerging market like China, where pharma companies adamantly want to market products. But Tufts' Ken Getz also questions whether developers are getting the savings they expect, adding that a reevaluation of offshoring development work may be underway.

"The economics are not nearly as attractive as once thought," Getz tells Hirschler. "Clearly, companies want to test their drugs in markets where they hope to commercialize a new treatment, so that is a driver for deciding where to conduct clinical studies. But given the increased operating costs and the inefficiencies, which can sometimes result in delays in some parts of the world, I think companies will begin to rethink just how many countries they wish to use."

- here's the feature from Reuters

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