Shifting clinical trials outside the US is “both economically efficient and ethically sound”, claim two University of Chicago professors.

If ethicists who argue that companies wanting their drugs approved by the US Food and Drug Adminstration should conduct trials in the US “win the day, it will add years to the length of trials and delay the introduction of new drugs”, warn Anup Malani, professor at the University of Chicago Law School and university fellow at Resources for the Future, and Thomas Philipson, Daniel Levin professor of public policy at Chicago University and chairman of the Manhattan Institute’s Project FDA.

Their opinion piece in the conservative Washington Examiner comes in response to concerns raised by a report published last month by the US Department of Health and Human Services’ Office of Inspector General. The report found that in fiscal year 2008, 80% of marketing applications for drugs and biologics approved by the FDA included data from clinical trials conducted outside the US.

Yet in the same year the agency inspected only 0.7% of foreign clinical trial sites, compared with 1.9% of US sites. Ethicists have qualms about the ability of local regulatory bodies and institutional review boards, particularly in developing countries, to monitor adequately data integrity and the protection of clinical trial participants’ rights and welfare. Other critics question the extent to which results from trials conducted in developing countries can be generalised to the US population.

Some medical ethicists, Malani and Philipson say, “used the report to insinuate that pharmaceutical companies were deliberately conducting foreign trials to avoid US ethical constraints and experiment on unsuspecting foreign patients”.

These concerns, though, “are exaggerated and ignore the complexities of modern clinical research”, they contend. For one thing, if the FDA and Congress push companies to conduct more studies within the US, then patients abroad “will lose the often valuable health benefits gained from clinical trials”. At the same time, US patients “will suffer from slower access to new, lifesaving therapies”, Malani and Philipson claim.

Pharmaceutical companies, they suggest, are victims of their own success. Saturation in the US market for clinical trials means recruitment is slower and more expensive on home turf.

“The vast majority of American patients already have access to a wide range of safe and effective non-experimental treatments, and generous public or private insurance to pay for them,” Malani and Philipson write. “So why would an American patient enrol in a trial for a new therapy that may or not work?”

By contrast, healthcare systems in Central and South America are less developed than in the US and patients in countries such as Peru and Columbia lack access to many of the treatments available in the US, the authors add. “They are willing to give informed consent to enrol in trials testing novel therapies, which often include more care and monitoring of their conditions than they would receive outside the trial.”

In a recent study for the Manhattan Institute, Malani and Philipson quantified for the first time the cost to patients of delays in drug development, finding that even a single year's delay costs patients “billions of dollars in terms of lost lives”. This “far outweighs the cost to companies of conducting clinical trials”, they comment.

The authors also suggest taking a more balanced perspective on the trend towards offshoring clinical trials. While the US accounts for just 5% of the world's population, it provides more than 20% of patients for clinical research.

“The reason for the disparity is that the US is responsible for almost one half of global research and development funding for new medicines,” they say. “Since the benefits of drug development are shared by the whole world, a proper balance of burdens would inevitably entail more, not fewer, clinical trials conducted outside our borders.”