Over the last several weeks, we’ve been examining the European clinical research industry and how it’s been under the influence of some significant global shifts. Our investigation has included a look at the differences between common perceptions and reality in the state of the market, as well as profiles of two EU countries that have shown themselves to be exciting, often overlooked hotspots of clinical research, eClinical potential, and healthcare.
Now, as our Europe series comes to a close, it’s time to address the elephant in the room: Europe today is witnessing, from afar, an explosion of clinical trial opportunity in eastern geographies on the other side of the world, while local growth has been slower. While the market is indeed growing in Europe as well, with an increase in the total number of clinical trials year after year, the continent’s share of the global market saw a 19% decline between 2010 and 2017 as regulatory reforms and other factors have caused a spike in places like China and India.
This has created both challenges and opportunities for EU-based researchers. While dedicated sites may find it more difficult to compete with the patient recruitment potential of up-and-coming regions, CROs and sponsor organizations have an opportunity to capitalize on the eastward shift. This, however, is dependent upon their willingness and ability to leverage the clinical trial technology resources, including but not limited to traditional eClinical technology, sweeping through the global clinical trial market.
The calm before an eClinical storm
We’ve talked a lot, on this blog, about the eSource revolution in clinical research – including how it can empower organizations to take advantage of these geographic shifts in the industry. By enabling real-time remote data sharing, eSource can eliminate monitoring-related logistical headaches like shipping paper data and long-distance monitor travel, and is thus key for organizations in Europe, for example, who hope to alleviate costs and facilitate patient recruitment by conducting their trials at sites in Asia. But real concerns of disruption and compliance persist around eSource – particularly in Europe, where the recently-enacted GDPR and other upcoming reforms have cultivated a sense of regulatory uncertainty that can make organizations wary of taking big steps.
But that all may be about to change. Last November, the European Medicines Agency (EMA) released its draft opinion on eSource direct data capture, a step that brought the regulatory body’s stance on eSource much closer to that of the FDA, which released its own guidance in 2013. Since the 2013 guidance, more organizations in the United States have implemented eSource in their clinical trials. And while it’s difficult to prove how much the guidance had to do with subsequent adoption, it’s not unreasonable to expect the EMA opinion to ease the nerves of European researchers who have eSource on their mind but have been reluctant to adopt.
The EMA’s draft opinion is still very preliminary. And of course, it doesn’t amount to a green-lighting of an eSource free-for-all. But it does indicate that the regulatory body, rather than staking its ground against eSource, is using regulation to optimize its use. In other words: it’s not “don’t use eSource,” it’s “here’s how to use eSource.” And if, when the opinion is more fleshed out, it opens the door to a broad definition of eSource that includes things like wearables, smartphone apps, and EHR-EDC integration, it could signal an eClinical renaissance for Europe. And that could bring Europe one big step closer to kickstarting its growth and making some real noise in the industry.