If you’re someone who keeps up with global trends in the clinical research industry, you’ve read a lot of stories over the last several years. There was the urgent search for vaccines when Ebola and Zika hit West Africa and Latin America, respectively. Precision medicine has stoked discussion of n-of-1 clinical trials taking the place of traditional models. But one of the most persistent topics during this time has been the trend of clinical trials migrating away from Europe in favor of geographies such as the Asia Pacific (APAC). This narrative may make it easy to see a European clinical research industry in decline, stifled by high costs and regulations. Evidence suggests, however, that such conclusions could be somewhat misguided. As Medrio continues to broaden our network of relationships with European CROs and sponsors, we’ve made sure to view the geographic trends affecting clinical trials in Europe in context. What has emerged are some lessons that paint a more hopeful picture.
1. Clinical trial migration does not equal a lack of innovation
While it’s true that the industry has seen clinical trials leave Europe and settle in APAC, this does not necessarily spell trouble for the European pharmaceutical industry. In fact, statistics show quite the opposite. R&D spending in both pharmaceuticals and biotechnology experienced growth, in Europe, from 2009 to 2016.1, 2 Over the same time period, that spending was increasingly directed toward Phase I clinical trials and less on Phases II and III,3 suggesting a greater focus on keeping the clinical trial pipeline supplied with newly developed products. These clinical trials may take place more often in China or Australia, but the trend indicates that pharma and biotech in Europe continues to innovate.
2. The tools are available to make Europe more clinical trial-friendly
Among the greatest factors behind the migration of clinical trials out of Europe are regulatory favorability in other geographies and the high costs of conducting trials locally. The former will be affected, for better or worse, by the new regulatory frameworks coming to Europe in the coming months and years, and it will be interesting to see how that plays out. As for the latter: There has never been as wide an abundance of technology solutions to mitigate the costs of conducting trials as there is today. Medrio has seen, firsthand, the effect of the efficiencies that tools like ours bring to clinical research. eSource empowers sponsors to save enormous portions of study budgets by reducing or eliminating the need for source data verification. API integration allows researchers to pay for eClinical solutions a la carte, as needed, rather than invest in one-stop-shop solutions that charge for a full suite of products that may not all be necessary. And the eClinical industry, in general, reduces costs associated with paper and the labor involved with storing and managing it. At Medrio, we’ve seen our users leverage these functionalities to offset the high costs of clinical trials in places like Europe and the US while remaining fully compliant with stringent regulations.
There’s reason to believe, however, that the European clinical research industry has yet to take full advantage of these tools. Recent reports show slow progress toward the adoption of artificial intelligence (AI) in clinical trials,4 and indicate that the industry’s interest in mHealth technology is not as high in Europe as it is in the US.5 Europe is, however, steadily stepping up its investment in those areas, and a greater embrace of technology, from AI to mHealth to modern eClinical software, could bring about efficiencies that mitigate some of the costs chasing clinical trials away.
Such an outcome would be positive for clinical research not just in Europe, but across the globe. With a worldwide increase in the number of new clinical trials registered over the last few years, clinical research doesn’t have to be an entirely zero-sum game. With the right tools and resources, Europe, APAC, and other regions around the globe can succeed in tandem. And this would be a win for patients everywhere.
1 European Federation of Pharmaceutical Industries and Associations, EvaluatePharma World Preview 2016, Outlook to 2022
2 Biotechnology Report “Beyond Borders” published annually by EY
3 The European Federation of Pharmaceutical Industries and Associations
4 Williamson, Jeanne-Francoise and Lubroth, Pable; Can We Predict Drug Efficacy with Artificial Intelligence?; Applied Clinical Trials, 22 May 2017
5 Burrows, Andrew; MHealth in Clinical Trials Report: Just 37% of companies utilize technologies; KNect365 Life Sciences; 23 May 2017