Why hold clinical trials in Eastern Europe? A new perspective on a growing trend

Shifting trends in clinical trial geography

Clinical trials are essential in the development of a new drug. In the past decades, clinical trials were traditionally performed in Western Europe and Northern America.

However, the cost of clinical trials has been increasing dramatically in the past few years. In response, pharmaceutical companies have started to look for solutions outside these traditional clinical trial regions. Eastern Europe recognized the opportunity and with a population pool of 315 M started to attract sponsors for clinical trials.

Full coverage of 17 countries

First, let us be clear what countries this region covers.

When speaking of Eastern Europe in this context, we include the following countries: Bulgaria, Czech Republic, Hungary, Poland, Romania, Russian Federation, and Slovakia, as well as the republics of Belarus, Moldova, and Ukraine.

Commonly the definition of Eastern Europe is expanded to include the following countries: Albania, Bosnia and Herzegovina, Croatia, North Macedonia, Montenegro, Serbia, and Slovenia.

The impact of universal healthcare on clinical trials

Due to globalization, over half of all clinical trials have been performed outside the USA since 2019.

Poland, Russia, Bulgaria, Czech Republic, Romania, and Ukraine are among the top 20 clinical trial participant countries worldwide in the period between 2015 and 2019 by share of participants.

So, what makes these countries stand out?

All countries in this part of Europe have one thing in common: universal healthcare, a government system providing mandatory public insurance to all people.

The state owns sizeable tertiary-care teaching hospitals and specialist institutes. Countries own health centers and the majority of general and specialist hospitals. Physicians increasingly provide primary care under contract with the insurance fund.

Even in the face of change and increased expenditure, Easter Europe proves to be attractively cost-efficient.

The strongest benefits of Eastern European trial sites

Transformation is often associated with vulnerability. In contrast, the health systems in Eastern Europe hold solid advantages for clinical trial conduct. In these countries, you can enjoy the following benefits:

• A centralized health system, which allows easier management and communication
• Quick access to a large number of patients at one site
• Study start-ups organized through clinical coordination offices
• Lower salaries and overhead costs in the region’s healthcare sector make them more attractive in regards to medical staff
• Co-operation with western companies in scientific research helps to improve medical workers’ positions
• Availability of a large number of teaching hospitals, university clinics, and postgraduate medical schools
• Medical practitioners actively seek the best medical care for their patients
• Cost of running a trial is lower than in the USA and Western Europe (clinical costs: investigator fees, site fees, monitoring costs, travel and accommodation costs etc.)

Are there any risks to holding clinical trials in Eastern Europe?

Eastern Europe often has negative connotations attached to it. There is a number of myths about conducting clinical trials in this region.

To separate myth from reality, we’ll address the most common misconceptions:

• Isn’t conducting clinical trials in Eastern Europe risky due to regulation deficiencies, complicated regulatory submission, unfamiliar bureaucracy, or delays in regulatory approvals?

A regulatory procedure that enables transparent and predictable regulatory processes and start-up timelines is essential for successful clinical trials.

Part of European Union countries like Hungary, Romania, Slovenia, Croatia, Bulgaria, Czech Republic, Poland, and Slovakia conduct clinical trials according to EMA’s regulations, which allows them to have simplified approval procedures.

Moreover, these Member States are fully compliant with all relevant EU directives, and keep up with every change and update. Others like the Russian Federation have internal standards that improve procedures and regulations according to the latest scientific and professional achievements.

The regulatory approvals can be gained within 60 days across several countries in Eastern Europe and Russia. The role of CROs in a clinical trial is crucial, especially in planning and task-consuming preparations, as well as in the adaptation of the necessary documentation to the applicable legislation and obtaining the required approvals from the ethics committees and regulatory authorities.

Regulatory submission and filing procedures should not be risky and complicated if you collaborate with a CRO with adequate regional experience.

• Is there enough expertise to conduct clinical trials in Eastern Europe and Russia?

You can always count on GCP standards. The basic procedures in Russia/Ukraine and Eastern Europe do not significantly differ from European or American trials, as national rules for conducting clinical trials are based on GCP.

Some deviations might be expected, but clinical research centers must implement measures to remain competitive.

• Is data quality adequate?

Implementation of ICH-GCP standards at sites and national authorities’ obligatory requirements gradually enhanced quality standards in clinical trials. Moreover, the high productivity of sites in Eastern Europe is accompanied by regulatory compliance and data quality standards.

Therefore, it is essential to hire a full-service CRO that can offer a full range of clinical trial services, including selecting investigators and clinical sites, assistance with patient recruitment, safety surveillance, reporting, site audits, and data management and biostatistics.

A European partner that spans both the East and West

Marti Farm is a Croatian full-service CRO that offers services for conducting clinical trials. Our team includes project managers, monitors, clinical trial specialists, and all necessary personnel to provide complete and quality service.

We have an individual approach to each client, so we can offer service at every stage of the trial from all phases (I, II, III, and IV). Above all, we can offer clinical trial support programs to all site staff which is included in the study. Our monitors are available 24/7 and are ready to answer all questions so we can ensure high-quality service to our patients, hospital team, and sponsors.

Only accurate and clear writing can convey all of the research and facts behind your work. Marti Farm offers a wide array of different scientific documents that efficiently present all of the information you need to report. Our team of safety monitoring experts covers all activities related to pharmacovigilance in clinical trials, with the support of local language experts.

That’s why we are the ideal European partner for clinical trials who never compromises quality for cost-effectiveness.

Zrinka Filipović, MSc / Business Development Associate