Clinical Trial Regulations: EU vs. US

Like in many other industries, business relationships in clinical research frequently span international borders. It’s common practice for a sponsor based in one country to conduct a study in another, due either to cost advantage, market opportunity, or other factors. When this happens, though, researchers must be vigilant in becoming familiar with, and adhering to, the regulations governing clinical trials in their host countries. As North America and Europe are current leaders in clinical research, it could be helpful to take a look at where regulations in these two regions overlap, as well as where they diverge.

Before diving into a more fundamental comparison, a note on one key area of divergence: registration requirements. In the U.S., Phase I trials are not required to register on In Europe, however, no such exception exists; all trials must register. And this leniency in the U.S. is not specific to Phase I: most trials in general have 21 days from the start of recruitment to register their trials, while in Europe, all registration must take place before recruitment begins(1). A sponsor hoping to conduct a Phase I trial in Europe would need to be aware of these discrepancies.


Different levels of government play a role

But perhaps the best lens through which to make this comparison is the governmental infrastructures of the U.S. and Europe; a parallel exists between the balance, in America, of the federal and state governments, and in Europe, of the centralized European Union government and those of its member countries. In the U.S., the federal government, through the Food and Drug Administration, dictates the rules regarding, among other things, the registration and reporting of clinical trials. However, a slew of additional requirements come from the state, not federal, level; these requirements can pertain to age of consent, informed consent, the study of specific diseases and disease classes such as HIV and cancer, and more(2). The obligation to simultaneously keep track of state and federal regulations can be cumbersome for sponsors, especially when conducting clinical trials across state lines, where regulations can change.

Across the Atlantic, Europe is grappling with a similar challenge. Differences in clinical trial requirements among various countries in the E.U. have made it difficult to conduct trials in two countries simultaneously. This has resulted in a significant drop in clinical trial applications in recent years. In response to this trend, the European Commission has designed a new paradigm which will place all E.U. countries under the same regulatory blanket. The primary objective of this reform is to avoid the legal and regulatory hodgepodge that often arises when a clinical trial spans two or more countries. Before this new system (known in shorthand as the Regulation) is implemented, Europe will need to establish a centralized clinical trial portal and database, a significant I.T. undertaking expected to be complete next year. Once implemented, the European research community hopes the Regulation will rejuvenate the flow of clinical trial applications, as well as create a regulatory simplicity that will attract foreign investment in clinical research on the continent(1).

If these goals are accomplished, it will be interesting to see who in the global research community takes notice and follows suit. American researchers may well appreciate a synthesis of federal and state regulations similar to that in Europe, especially if there’s evidence that it would catalyze activity, investment, and progress in the industry.