The findings of the recent HHS study showing large numbers of clinical trials conducted outside the U.S. should come as no surprise to followers of the drug development process. It is extremely expensive to create new products—averaging 10 years and a billion dollars—and companies understandably are on the lookout for cost savings.
Conducting trials abroad is often cheaper since the FDA requires fairly large trial sizes and it is expensive and difficult to find sufficient numbers of Americans to participate. But running trials outside the U.S. does not necessarily make the products less safe or mean that companies are cutting corners when it comes to safety.
FDA's standards remain just as rigorous regarding data and trial size, regardless of where the trials take place. And from the company standpoint, playing fast and loose with the data risks upending a billion dollar process.
The HHS recommendations—especially the suggestion that FDA standardize its data collection process and create an internal database—are generally sound. But a sudden discovery of the well-known fact that many trials take place abroad should be no reason for panic.