The problem with outsourcing clinical trials

And, from the Annals of What s Wrong with Outsourcing, a new study suggests that clinical trials conducted outside the U.S. may not be a reliable indication of a drug s efficacy for its intended American population. The study, just published in the Journal of the American College of Cardiology, found that beta blockers had no effect when tested on U.S. populations, even though they did successfully extend lives in clinical trials that took place in other countries. After researchers from Duke University Medical Center looked at the clinical trial data from a total of about 9,000 participants, they discovered that beta blockers cut deaths among non-U.S. patients by 36 percent, while there was no statistically reliable drop among U.S. patients.

Although it isn t clear what s to account for the disparity between patient populations, researchers have some initial theories: they speculate that it could be due to different uses of medications or devices to control heart failures, or that genetic differences might be at play. (For instance, African Americans more frequently have a gene variant that renders them less responsive to beta blockers than the average white patient). Yet regardless of the explanation for the discrepancy, the study suggests that drug developers need to be attentive to how relevant the makeup of a clinical trial population is to the patients for whom the drug would ultimately be prescribed.

The study highlights yet another problem with the ubiquitous practice of outsourcing, says ACSH's Dr. Josh Bloom, who is well versed in the adverse effects that this practice has had on the pharmaceutical industry. By conducting most of our clinical trials abroad, we are developing drugs that are maximally effective for those in other countries, and not necessarily for us.