According to recent research, the process of choosing countries for conducting clinical trials may turn out to be quite costly. Moreover, the process abounds with risks of delays in site activation bringing to disruption of developmental timelines and loss of up to two-thirds of enrolment time.
Central and Eastern Europe region (CEE) may be the best location for your next oncology clinical trial. Featuring the lowest level of challenges among emerging regions, this location provides a population pool wide enough to provide for quick recruitment of the desired number of patients. So, your site options do not have to be limited to those in the USA and Western Europe.
Unique Characteristics of the CEE Region
Major attractions of the Central and Eastern Europe region for clinical research are as follows:
- healthcare characteristics
- patient access for recruitment
- stabilized start-up regulations and rules
If 3 decades ago the majority of clinical trials were conducted in Western Europe and North America, today the share of these traditional clinical study markets shrank to less than two-thirds. The list of locations suitable for conducting clinical research was expanded on the basis of such features as:
- quick availability of patients (particularly naïve patients treatment);
- relevant disease profile for a variety of therapeutic areas.
Contrary to expectations, the highest growth rate of clinical sites in a five-year period (12%) was reported in CEE region. Along with such hard parameters as population size, geography and cost of medical research, this growth is based also on such “soft” factors, as availability of qualified local staff, high motivation of all stakeholders, and supportive environment.
CEE region consists of 20 countries with a diverse population of about 340 million. And it is quite reasonable that several CEE countries are among the world’s 10-15 leading clinical research destinations.
Fast Patient Recruitment
To identify and recruit patients who meet protocol criteria (in/ex) of the given clinical trial is an easy and quick process in CEE region. Naturally, this factor is major attraction for conducting clinical trials in Europe. Such advantageous condition is possible due to national health insurance system of those countries. It provides centralized healthcare, funneling patients into specialized, well-equipped medical centers and treating vast numbers of patients at one site. Another crucial aspect of Eastern European countries (unlike Western Europe and North America) is homogeneity of their populations as well as treatment approaches.
On patients’ end, clinical studies in CEE region offer such benefits as access to cutting-edge medications and advanced therapies otherwise inaccessible to them because they are not covered by state reimbursement programs. This triggers an ever-growing competition among patients – including a lot of treatment-naïve ones – to participate in that kind of medical research.
These factors are especially beneficial for oncology trials designed with the focus on specific candidates. Involved in clinical studies are not only National Oncology Centers but also University hospitals and a lot of oncology departments of regional hospitals across the country. Thus, depending on the country size, the number of sites varies between 12 and 15 (in Hungary, Romania and Czech Republic) and 15 to 25 and more for countries the size of Poland and bigger. Most of the countries in CEE region are involved in 80–120 ongoing clinical trials in oncology (the average number listed in the EU register of clinical trials), providing an almost 100% of required patients.
If in the last decade 40-50% of western sites failed to provide the required number of patients for Phase II and Phase III clinical trials (with 11% of sites failing to enroll even a single patient), in Central and Eastern European countries it is right the opposite. Patients actively enroll in clinical research to diversify their treatment options and reduce its cost to the state healthcare system. Thus, everyone stands to benefit – patients, states and clinical researchers. The latter also saves the significant waste of financial and human resources as well disruptions to developmental timelines – all caused by the lack of patients for clinical trials.
Compliance to EMA Regulations
Regulatory environment that provides for transparent and predictable regulatory processes and start-up timelines is crucial for successful clinical research. Part of European Union countries like Hungary, Romania and others adhere to EMA (European Medicines Agency) regulations, which allows them to have simplified approval procedures and a more predictable, 55–60 day timeline. However, a number of countries (like Russia, Serbia, Ukraine, and Turkey) have internal standards of their own.
Another complex issue is study start-up (SSU), with one of its major risks being the lack of trained local staff acquainted with procedures and involved in the process. Today, with CRO environment having a defined local start-up team, it is possible to manage site and country specific aspects, allowing to jump-start clinical research at the site level and also accelerate patients’ joining the trials.
Higher Clinical Data Quality through Higher Stakeholder Adherence
As mentioned above, patients in CEE countries benefit greatly by participating in medical research. Nevertheless, they are not the only motivated stakeholders in this process. Researchers and investigators consider clinical trials as a unique opportunity to advance their careers through working with cutting-edge medicine and therapy. Access to new treatment gives them also international experience in certain areas of medical science.
This high stakeholder motivation results in procedural and regulatory compliance better in CEE countries than in Western Europe, the USA and the rest of the world according to FDA site inspection reports. These inspections found fewer issues with record keeping and protocol compliance, as well as with documents and procedures of informed consent. And when it comes to clinical data quality, it is acknowledged as “not inferior to those in Western countries”.
According to the results of over 230 inspections FDA conducted in CEE countries, the number of clinical trials in Central and Eastern Europe with “no deficiencies” resolution from FDA was two times higher than in the USA or Western Europe.
Thus, benefits of adherence when conducting clinical studies in Europe outweighs whatever additional costs, such as translation of trial materials and protocols to local languages, and any study-specific training.