MediciGlobal

In a June 21, 2010 article published by The New York Times, US Congresswoman Rosa DeLauro, (a Democrat from the State of Connecticut) criticizes the pharmaceutical industry’s placement of clinical trials abroad. She says that: “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.” Adil Shamoo, editor of Accountability in Research, adds that “With foreign trials there is less liability, patient recruitment is far easier, the concept of informed consent is not well established, and it’s cheaper.”

In this debate, biopharma companies and clinical research operators are highlighting that rising costs are a legitimate concern and, moreover, clinical investigators in the US appear less interested in participating in studies. A recent survey by the Association of Clinical Research Organizations found that between 2004 and 2007, the number of clinical trial investigators who are regulated by the FDA fell 5.2 percent in the US and 6.1 percent in Western Europe, while increasing 16 percent in Eastern Europe, 12 percent in Asia and 10 percent in Latin America.

Clinical investigators in the US report that the low clinical trial participation rate is due to the fact that regulations make trials difficult to manage, medical liability, and conflict of interest mandates that docs disclose financial relationships with pharma. In fact, 24 percent of US investigators are less likely to participate in trials if they are required to disclose income. 

As this debate gains ground with members of Congress, what implications do you believe this could have on our industry?

http://www.nytimes.com/2010/06/22/health/research/22trial.html