Wednesday, August 4, 2010

Foreign Clinical Trials: Bye Bye, U.S. Trial Investigators

Can we say for certain that industry is conducting more clinical trials overseas because fewer U.S. physicians, who once ran those trials, don’t want to see their remuneration made public?

Probably not, but what we can say is this: It is a factor.

A week before the Inspector General of the Department of Health and Human Services published his report saying that most drugs approved in 2008 were based on trials conducted in foreign countries, Pharmalot published a survey, conducted by the Association of Clinical Research Organizations.

ACRO found that between 2004 and 2007, the number of FDA-regulated trial investigators was dropping in the U.S. and Europe, and climbing in Eastern Europe, Asia, and Latin America. The reasons cited: medical liability, COI rules, and regs that physicians must publish financial relationships – 24% of U.S. investigators were “less likely” to be involved if they had to disclose what they made. U.S. investigators are more interested in making money than their peers in Western Europe – 68% vs. 26%, according to the report.

For those of you who missed the IG’s report: It looked at 121 approved drug applications. Of these, 80% “contained data from foreign clinical trials.” The vast majority of trial participants were not Americans. The vast majority of sites were not FDA-inspected.

This trend is expected to continue, and expand into countries like China. The FDA didn’t inspect sites in countries where political relationships are generally just fine; are we going to get into China? In 2008, the FDA examined .7% of foreign clinical trial sites, and 1.9% of domestic sites. And that, of course, is if the company has even filed an IND. The “FDA may be unaware of some ongoing, early-phase clinical trials because sponsors are increasingly conducting early-phase clinical trials outside the United States without INDs,” the report said.

The agency agreed with the IG’s recommendations to improve the situation, including standardizing electronic data filing and creating inspection agreements with oversees regulatory bodies. Anyone remotely aware of the problems involved with conducting clinical trials these days knows it will take more than the IG’s recommendations to reverse the overseas trend.

Here’s an idea on paying U.S. clinical investigators: Perhaps the solution calls for something like a blind trust. All those industry members conducting clinical trials in a particular year would throw money in a pot, and clinical investigators would be paid from that pot. Their names would be published, but not aligned with any one drug, or industry member.

Is it a dumb idea? Maybe. But we need ideas. Dumb ones can spawn good ones.

Transparency is all well and good, but as we’ve said before, we need to find ways to keep industry and physicians working together, or the medical progress we’ve enjoyed will be compromised. 

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