Ask an economist to name the most defining business trend of the 21st Century, and there’s a strong chance the answer will be globalization. Nations and regions are becoming increasingly intertwined through trade and outsourcing. Clinical research is no exception to this trend. Multi-country clinical trials have risen in recent years, and new regions have emerged as today’s most promising venues for clinical trials. The major forces behind these changes include the varying degrees of regulatory friendliness and access to patient populations in different countries around the world.1 Of course, cost plays a major role as well, as researchers have become increasingly attracted to developing regions where the cost of conducting a trial are considerably lower.
But it would be naive, of course, to think that researchers can simply pick up and move their operations to China and expect the challenges they’ve faced to evaporate. In exchange for the relief they may get in areas like patient recruitment, researchers will be confronted with one of the most important considerations as clinical trials go global: the burden to localize. What are some of the major pillars of the localization process for companies moving their clinical trials overseas?
1. Regulatory concerns
Regulatory flexibility in a given country is a common incentive for a sponsor to shift clinical operations to that country from another. However, this of course doesn’t mean that today’s emerging clinical research hotspots are promising researchers a regulatory free-for-all. While regulations may be more permissive in one country compared to another, it’s still essential for researchers to know the differences in the frameworks of their host country and home country. Clinical research – an industry in which human health, safety, and even lives are on the line – is subject to intensive regulation, and compliance is essential no matter where a trial takes place.
This can get tricky, however, at a time of uncertainty and change at some of the world’s major regulatory bodies. In Europe, for instance, a new regulatory framework that will affect all countries in the European Union is expected to take effect in 2019, with its rollout complicated by recent mitigating factors like Brexit. Researchers with an established history of conducting trials in Europe, and who have a strong understanding of European regulations today, may find themselves with new localization work to do in the next few years.
These regulatory considerations are closely entwined with another important process for global clinical trials: language localization. In an industry characterized by strict and sensitive compliance standards, accurate translation and interpretation during the clinical research process is paramount. Slator, an organization with expertise in translation and language technology, recently convened a roundtable of industry experts to discuss this issue and others, pointing out the particular importance of language localization in the Asia Pacific region, a major hotspot for clinical research today where few countries speak English natively and where cultural sensitivity can make translation particularly tricky.
3. Vendors in global clinical trials
Localization in global trials is a holistic process – CROs aren’t the only vendors held to the standards it entails. If an EDC solution isn’t able to offer functionality in the languages of the countries where its studies are conducted, its users can face serious impediments in getting their studies done in time and getting their drugs to market. Likewise, if an EDC solution doesn’t comply with clinical trial regulations in the regions that are attractive to sponsors today, its customers’ ability to reap the benefits of international outsourcing can be significantly curtailed.
For these reasons, it’s imperative for eClinical software vendors to get with the times. If EDC isn’t able to localize to a broad range of popular research destinations, its own business isn’t all that suffers – the sponsors depending on it can find themselves stuck as well. Medrio has avoided this pitfall with a strong focus on regulatory compliance. Not only is the software compliant with a wide range of U.S. regulations, it has also been used in studies submitted to all major regulatory bodies around the world. And Medrio’s recent localization into Japanese better enables researchers to get in on the action in the Asia Pacific.
The continuing trend toward global clinical trials has promising implications for researchers. But it has also placed localization, a multifaceted and often challenging process, in a much more prominent position among the concerns of the clinical research industry. For researchers and eClinical vendors alike, an orientation toward international paradigms is essential as clinical trials continue to cross borders.
1 Li, Rebecca; Barnes, Mark; Aldiner, Carmen E.; Bierer, Barbara E.; Global Clinical Trials: Ethics, Harmonization, and Commitment to Transparency; Harvard Public Health Review; 2015