A new report from the inspector general of HHS highlights just how dependent drug developers have become on overseas clinical trials. And the New York Times raises some serious questions over the kind of regulatory oversight, or lack of it, that foreign drug trials are subject to.
According to the HHS report, 80 percent of all the drugs approved in 2008 relied on foreign trials to some extent, with 78 percent of all enrollees recruited at foreign sites. And a total of 10 new drugs were approved without any data from U.S. clinical trials.
The FDA rarely audits any trial, but the agency did inspect 1.9 percent of U.S. trials, compared to only 0.7 percent of foreign trials. And U.S. critics of the trend have raised an alarm. "By pursuing clinical trials in foreign countries with lower standards and where FDA lacks oversight, the industry is seeking the path of least resistance toward lower costs and higher profits to the detriment of public health,"said Connecticut Representative Rosa DeLauro.
None of those numbers, though, are likely to be a big surprise to anyone in drug development. Developers have been steadily shifting trials to less expensive sites, and R&D in places like China has been exploding. The key concern in drug circles now is that countries like Russia have allowed trials that produced dubious results, leading analysts to question the reliability of the data. But don't expect any sudden change in the trend. Foreign drug trials have become a permanent feature of international drug development.
- here's the article from the New York Times