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Central Europe – Look Behind the Curtain of Trials for On The Ground Knowledge

In the last 5–10 years we have seen global sponsors and global CROs increasingly looking to open investigator sites or acquire resources in Central and Eastern Europe. Following the recent Bio Europe – where eastern Europe site options were a hot topic among execs –Pavel Marek, Managing Director of Emmes Europe, shared his view on what’s ahead in the region for the next few years. In particular, he explores the growing role Central and Eastern European trial sites are now playing in early-stage trials.

To understand what’s driving the region’s growth you need to look at its recent history and the underlying trends. So, for example, most of the recent trial expansions have primarily benefited Central European countries. These countries joined the European Union (EU) in 2004 and fully implemented the harmonised EU directives and regulations a long time ago. So now these countries in Central Europe can offer the combination of high standards of healthcare, high-quality site staff, and very good access to patients with relevant diagnoses. Delving deeper, much of this was empowered by the centralisation of healthcare in the region – whereby public healthcare grants provide access to modern therapies for the entire population. But to keep costs down, healthcare payers (like state insurance companies or state sick funds) designed specialised centers with a strong diagnostic infrastructure and highly qualified healthcare staff authorised to prescribe the expensive innovative therapy. Consequently, this clustered the experience of the newest therapies and most experienced clinicians. However, that’s not to say there are no challenges, and the difference between success and failure will be how a CRO marries this upside with solutions to overcome regional complexity. For example, as a region of many disparate countries – despite a common regulatory framework – there are a number of hard and soft barriers. So that means often subtle differences in the implementation of EU rules – sponsors are often surprised by this – combined with local language barriers. Not surprisingly, and hardly unique to Eastern Europe, it means inevitably there is a great deal of value CROs can deliver from good hard yards on the ground and local experience – it’s easier enough to open an office here but much more difficult to replicate the knowledge to seamlessly navigate eight languages, regional practices, and vagaries of receptive patient populations. Yet operations driven from Central Europe give you the unique combination of access to: centralised hubs, the traditional big EU countries (which are attractive for global sponsors as strategic markets for future launches), as well as the very productive Central European countries generating high-quality clinical data relevant for the EU population and Eastern European countries.

The other obvious advantage of the region is its access to patients. Operations in Central Europe are an excellent base for further expansion in neighboring Eastern European countries, where the density of clinical trials is still much lower than in other comparably regulated markets. Less trial competition of course in itself brings a number of further advantages beyond patient recruitment as it automatically improves quality. This is because the sites can stay focused on just one or a few projects running in parallel. They can provide patients with that, all too underrated, trial benefit, increased doctor-patient time. Clinicians can therefore concentrate more on patients and become the real experts on protocol and all study-related procedures in a relatively short timeframe. Dedicating significant time for direct communication between investigator and patient, addressing all questions and concerns of the patients or their families carefully. Ultimately, this translates through to the Sponsor as an improved adherence to study protocols, with minimum dropouts and protocol deviations. Looking further ahead, this also helps deliver positive outcomes during FDA or EMA inspections at the sites that can observe this firsthand. Speaking of regulators, another previous hesitance has been the sheer number of countries here, but there is an ever-increasingly harmonised environment here. In fact, all 27 EU member states now follow one legislation related to clinical research. Obviously, there are some local differences in its implementation; however, for CROS with history and local presence in these EU states, it can be relatively easy to address.