NEW Clinical Trial Opportunities in the CEE

Historical data, based on the number of clinical trial sites in the region reported a staggering growth rate of over 12% between 2008-2013 (1). All global CRO’s and multinationals have now established locations in CEE countries including Poland, Czech Republic, Bulgaria and Hungary. Consequently, it’s not surprising that we see the number of pharmaceutical and contract research companies in the region continue to grow.

With strong government support to develop transparent application procedures, such as the single-route submission implemented in Hungary. The timeline for approval procedures are cut short, so trials can begin earlier. This regulatory acceptance and validation demonstrates that the CEE countries are ensuring they remain the destination of choice for delivering clinical trials in Europe.  

The CEE is characterised by a population of approximately 345 million inhabitants across 20 countries, each with differences within population and clinical trial expertise. With these resources it was inevitable that many CEE countries established themselves within the top 20 countries on the global list of clinical trial delivery. However, this growth is not based solely on population size, but also on a number of other factors, such as cost, geography, supportive business environments, access to qualified local staff, high productivity of sites, regulatory compliance and high data quality standards that equal to those in Western regions.

Geographically situated in a convenient location close to Europe the CEE is considered a cost-effective option. The price of delivering trials in CEE countries varies depending on the country selected, but it still remains significantly lower than trials delivered in Western Europe. In addition, sponsors delivering trials in the region found travel and accommodation for staff visiting sites were much lower than Eastern counterparts ensuring costs are kept to a minimum.

The lack of geographical mobility of residents from the CEE countries makes it a reliable choice to conduct successful clinical studies and trials (2). Residents of the CEE region are less geographically mobile than Western European counterparts making it easier to carry out long-term treatments and effectively monitor prolonged follow-ups for trials. This critical success factor has led to a significant increase in the number of internationally sponsored clinical trials being delivered in the region.

The large population of the region promises access to a pool of compliant patients for clinical development programs. The availability of patients in these countries with certain medical conditions that meet study selection criteria, and their willingness to participate are the primary drivers behind instigating CEE sites. Consequently, many pharmaceutical companies including Novartis, Merck and Roche use the CEE region to deliver multi-center, multi-country trials. The advantage of large patient populations in the same region ensures that significant time and cost savings are achieved for multinationals.

Investigators and study teams within the region are motivated to partake in trials as scientific opportunities encourage links with the wider international community. Analysis of data from 50 international phase II and III clinical trials has shown that the mean site productivity (estimated as patients enrolled monthly in each site) in the Balkans is twice that in the USA and Western Europe3. Combined with the relatively cost-effective delivery of trials and the number of highly skilled investigators in the region, it becomes even more attractive.

Since 2004, the Baltic States as well as Hungary, Poland, Romania, Czech Republic, Slovenia and Slovakia embraced the European Union bringing them under the jurisdiction of the union’s legislation and guidance for clinical trials. Implementation of the European Union’s Directive on Clinical Trials (The European Parliament, 2001) and the GCP directive (The Commission of the European Communities, 2005) has informed intensive and detailed practice of GCP principles among stakeholders and also improved the regions application to carry out clinical trials.

The regions enviable record of clinical delivery to global standards is also a winning factor when considering trial locations. Eastern Europe includes nations that are within the European Union (EU) and adhere to EMA guidelines. Many research centers in the CEE are passing inspections first time, revealing the high standard of results from CEE clinical trials. The FDA’s site inspections reported good protocol compliance and record keeping as well as fewer issues with informed consent documents and procedures in the CEE compared to Western Europe, the USA or other parts of the world. This data suggests that the high productivity of CEE sites is accompanied by regulatory compliance and clinical data quality.

With all the advantages the region has in terms of patient compliance, stakeholder commitment, the supportive health environments, access to qualified local staff, high productivity of CEE sites accompanied by successful regulatory compliance, good data quality standards and lower costs, the CEE remains an attractive option to deliver clinical trials.

1.     Misik et al, Globalization of Industry-Sponsored Clinical Trials. Applied Clinical Research, Clinical Trials & Regulatory Affairs. 2014; 1:1.

2.     Gambrill S. Central and Eastern Europe triples global trial participation. Centerwatch Monthly. 2008; 15:8–17.

3.     Tassignon J-P, Sinackevich N. Speeding the critical path. Appl Clin Trials. 2004; 13:1:42–48.file:///E:/Users/nkilmart/Desktop/Tahira/Adamsmith/CT%20CEE%202018/Brochure/NEW_CEE_Opportunities.pdf