spacer
home > ict > winter 2013 > cee for yourself
PUBLICATIONS
International Clinical Trials

CEE for Yourself

When compared to other emerging markets, Central and Eastern Europe (CEE) is often distinguished by its highly diverse mix of cultural, economical and healthcare climates. When applying these influences to clinical research, there are wide-ranging differences across the region that drug developers must consider when advancing new therapies globally.

For example, in Russia – the region’s largest market – unpredictable regulations and difficult logistics frequently challenge trial efforts. But in the smaller Czech Republic, along with the Baltic states and Slovenia, where health systems and standards of care are similar to those in the West, clinical development paradigms are strong.

Nevertheless, with the number of studies initiated in CEE having more than tripled over the past five years, the need for biopharma companies to better understand the region’s varying dynamics is critical (1). Equally as important are efforts by global contract research organisations (CROs) to account for these intricacies when executing trials in the region.

Growth Spurt
CEE has evolved over the past 15 years into an attractive market for launching drug development programmes. In Central Europe – specifically, Bulgaria, Czech Republic, Hungary, Poland, Romania and Slovakia – the number of new clinical studies is predicted to rise by seven per cent in 2014 (2). According to clinical trial listings posted on CenterWatch.com, as of September 2013 there were 2,225 entries of sites actively recruiting patients in Poland; 1,438 in Hungary; 1,332 in Romania; 1,318 in Czech Republic; 579 in Bulgaria; and 570 in Slovakia.

Russia also remains an appealing destination for clinical research, despite its traditionally challenging environment. There were close to 2,700 trials ongoing in the country in 2012, and the number of studies hosted by foreign companies has tripled in the last decade (3,4). Furthermore, a recent report by the European Medicines Agency (EMA) found that during the 2005-2011 period, Russia ranked third in the world in the number of pivotal trials included in marketing authorisation applications submitted to the EMA, trailing only the US and Canada (5).

In Ukraine, there were 983 active recruitment programmes as of September 2013, according to CenterWatch. With 46 million citizens, Ukraine is already recognised for high recruitment, a huge pool of treatment-naïve patients and high-quality data delivered on time. Meanwhile, in Belarus, only the public sector can apply for clinical trials accreditation. There are reportedly just 59 research sites accredited as such in the nation (6).

Patient Pools
The overall access to large pools of treatment-naïve patients is a major draw for organisations hoping to expand the testing of their products in CEE. Helping matters is the favourable environment for patient recruitment and retention. In the region’s more economically challenged countries, many important therapies are not reimbursed, thus providing an added incentive for patients to participate in trials.

CEE’s collective population is greater than that of the US, and is also more than the five largest Western European markets combined (7). The region has benefitted from periods of significant Asian migration – a trend that flourished during 1995-2005 (8).

A consequence of CEE’s large population is poor disease detection and prevention, and, therefore, higher prevalence of late-stage diseases. In addition, the global diabetes and obesity epidemics have been felt heavily in the region – since 1989 the number of cases has risen sharply, with the highest increase in countries undergoing rapid Westernisation (9). Cardiovascular and metabolic disease is an especially active area for therapeutic research, along with oncology.

Contributing to the latter are the continued after-effects of the 1986 Chernobyl nuclear power plant accident in Ukraine, and the increasing numbers of resulting cancer cases that have been diagnosed.

Clinical studies targeting chronic indications in immunology and inflammation, most notably rheumatoid arthritis and systemic lupus erythematosus, are also prevalent across CEE, particularly in Poland, Czech Republic and Hungary. In fact, Poland currently has more trials ongoing in rheumatoid arthritis than the US.

Driving Progress
Beyond patient access, there are several other notable growth drivers of clinical research in CEE. One is operational cost savings. In Eastern Europe, for example, the average cost per patient is reportedly 28 per cent lower than in Western Europe and 47 per cent lower than in the UK (10).

Another driver is the wide use of centralised health systems in CEE, which have taken advantage of the region’s improved infrastructure to establish large medical centres. These centres allow principle investigators to more quickly recruit patients from the regional population, thus assisting large-scale studies.

In addition, due to the proximity of CEE countries to Western Europe, the local investigator knowledge base is similar. Over the last decade, physicians have gained significant experience, training and motivation in performing trials. In most of CEE, the sponsor pays the investigator and the site separately, with the investigator reportedly receiving 70-90 per cent of the total grant directly (11).

Quality Control
Rapid study start-up is another appeal. Latvia, a country of just two million people, is considered to have the region’s most favourable start-up timelines, benefitting from better overall quality control. CEE countries have demonstrated improvements in regulatory oversight, and according to the US Food and Drug Administration inspection database, the quality in CEE is equal to or better than other regions of the world (11).

Investigators are also increasingly participating in the data collection process, which can help drive up quality. For sites in Central Europe, in particular, the documentation requirements to conduct clinical trials have eased somewhat in recent years. In most of CEE, import licences are no longer required, which has improved the reliability and speed of approval processes.

Unique Challenges
However, despite the region’s market appeal, there are several unique challenges to consider. Many are connected to the continued shortage of funding for the healthcare sector. For example, site equipment maintenance and calibration are frequently low priorities, particularly at rural sites. Also, with no electronic medical records in much of CEE, sites retain much less information about their patients in individual files (11).

Regulatory climates are still far from ideal in some CEE countries. For instance, Russia recently changed its regulations around patient insurance, making it more difficult to enrol trials. The country has also overhauled legislation that may affect foreign-led clinical studies, with new drugs now required to be tested in Russia prior to registration.

Russia already requires international biopharmas to share their expertise and technologies with domestic companies or face trade restrictions (12). Poland introduced significant changes to its drug reimbursement system in 2012, and Hungary recently instituted regulatory changes too (13).

Logistics and Contracts
Logistical issues are a further consideration. These are especially prominent in Russia, Ukraine and Serbia, where import/export laws often complicate the shipping of samples to a central laboratory, as well as the import of devices used in clinical research. For instance, for larger trials in Russia which rely on a central lab, including sites outside of Moscow and St Petersburg is usually not efficient.

Contract negotiation with sites is perhaps the most worrisome challenge in CEE. Changes in management occur frequently at hospitals across the region, and each time result in new governing structures and legal policy. This can severely slow negotiation timelines with sites and investigators, sometimes up to as much as four months in certain countries. The process is often a burden on clinical study start-up activities, given that site contracts are part of essential document collection and sites cannot be initiated until contracts are finalised.

Building Site Relationships
The ability to strengthen relationships with sites is critical to optimising the clinical trial efficiencies CEE can offer. However, understanding and supporting sites in the region can pose problems. It is important, therefore, that biopharmas leverage CRO partners that have not only global capability support, but also strong localised presence and experience with the intricacies of launching and running studies in these diverse countries.

Also crucial is the responsibility of establishing and maintaining appropriate communication channels with sites. Incorporating clinical research associates (CRAs) and central monitoring associates (CMAs) as primary points of contact is one way to ensure continuous communication and follow-up. The benefit of a CRA in this role is that the individual will always be of the same nationality as the site’s based country.

Involving CMAs can help to optimise the communication process in cases when CRAs are travelling and communication windows are tight. Office-based CMAs are able to gain immediate access to different systems to address issues brought up by the site, and provide answers in a timely manner.

Focused Training
CRAs and CMAs work together, are trained on the same tools, and share one standard operation procedure for the clinical trial management system being used. With large numbers of CEE physicians, pharmacists and biologists involved in clinical monitoring, CRAs and CMAs in the region are uniquely positioned to respond to potential data quality issues and ensure that proper training is conducted consistently across all sites in a trial.

These groups can also help manage potential language barriers in global trials involving sites in CEE. Many CMAs/CRAs hired in the region are fluent in several languages.

Academic communities in CEE also see the value in more focused clinical trial training. For instance, an increasing number of medical institutions in the region have launched courses and master’s degree modules for teaching management of clinical studies.

References
1. The 6th Oncology Clinical Trials in Emerging Regions Congress 2013. Visit: www.clinical-trials-events.com/oncology.html
2. Stefanczyk M, Almost 2,300 clinical trials to be conducted in Central Europe in 2014. Visit: www.paiz.gov.pl/fi les/?id_plik=18296
3. Clinical research in Russia – regulations and trends, International Conference and Exhibition on Pharmacovigilance & Clinical Trials presentation, 2012. Visit: www.omicsonline.org/2161-1459/2161-1459-S1.004-001.pdf
4. Russia clinical trial market opportunity analysis, Kuick Research, 2013. Visit: www.researchandmarkets.com/research/kzz57w/russia_clinical
5. Clinical trials submitted in marketing authorisation applications to the European Medicines Agency, EMA, 2013. Visit: www.ema.europa.eu/docs/en_GB/document_library/other/2009/12/WC500016819.pdf
6. Clinical trials in Belarus, Biomapas, 2012. Visit: www.biomapas.eu/news/clinical-trials-belarus
7. Expand clinical capabilities throughout Central and Eastern Europe, Cutting Edge Information, 2010. Visit: www.cuttingedgeinfo.com/research/clinical-development/central-eastern-europe-trials/
8. World Migration 2008: Managing labour mobility in the evolving global economy, International Organization for Migration, 2008. Visit: http://publications.iom.int/bookstore/free/WMR_1.pdf
9. Jarosz-Chobot et al, Rapid increase in the incidence of Type 1 Diabetes in Polish children from 1989 to 2004, and predictions for 2010 to 2025, Diabetologia 54(3): pp508-515, 2011. Visit: www.ncbi.nlm.nih.gov/pmc/articles/PMC3034048
10. Market, SPRI Ukraine, 2013. Visit: www.spriukraine.com.ua/market.html
11. Niedzielska DL, The reality of clinical trials in Central and Eastern Europe, Journal of Clinical Research Best Practices 9(5), 2013. Visit: http://www.fi/ rstclinical.com/journal/2013/1305_CEE.pdf
12. New Russian pharma and medical device legislation is a reality, Moravia Blog (published 4th April 2012). Visit: http://info.moravia.com/blog/bid/126816/lex-russia-new-russian-pharma-and-medical-devicelegislation-is-a-reality
13. Moderate growth seen in Polish clinical trials market, PharmaTimes (published online 5th July 2012). Visit: www.pharmatimes.com/article/12-07-05/moderate_growth_seen_in_polish_clinical_trials_market.aspx


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer

About the author

Marcin Ernst is Executive Director of Clinical Development at INC Research. As the Site Head for INC Research Poland, he leads the Immunology and Infl ammation group, which is responsible for delivery of projects globally in this therapeutic area. Marcin has 12 years of experience in clinical research, both in CROs and pharma. He previously worked as a general and cardiac surgeon.

Cristina Stefanescu is Director of Clinical Operations at INC Research, Czech Republic. Cristina leads clinical development activities, as well as postapprovaland strategic services, for the Cardiovascular and Endocrinology group, and is responsible for projects within CEE. She has 13 years of experience in clinical research.

spacer
Marcin Ernst
spacer
spacer
spacer
Cristina Stefanescu
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

PCI Pharma Services Announces Further Expansion in San Diego to Maintain Industry-Leading Quality, Service and Flexibility

Philadelphia, PA – June 4, 2019 PCI Pharma Services (PCI), a leading biopharmaceutical outsourcing services provider, has announced the growth of its West Coast Clinical operations with expansion into its third facility in San Diego.
More info >>

White Papers

Sterile Vials Made of Tubular Glass

Gerresheimer AG

Gx® RTF vials powered by Ompi EZ-fill® enhance flexibility by facilitating packaging needs from clinical stage to industrialization with the common goal to minimize customer product risks and optimize total cost of ownership. Gerresheimer combines the competencies in converting glass tubes to serum/ injection vials and ready-to-fill processing for our pharma and biotech customers.
More info >>

 
Industry Events

SCOPE Europe – Summit for Clinical Ops Executives Europe

17-18 September 2019, Barcelona, Spain

Building on the success of its long-running US-based counterpart, Summit for Clinical Trials Operations Executives Europe (SCOPE Europe) is a two-day event serving clinical innovation leaders, clin ops execs, functional heads, category managers, and those responsible for the planning and management of clinical trials in Europe and the Rest of the World. The event will feature opening and closing plenary keynote sessions, five conference tracks, interactive breakout discussion groups, and networking. It is an opportunity for leaders from large, mid-sized, and small pharma, specialty pharma, biotech, vendor companies, and academic research centers to come together to share best practices and discuss the new era of analytics-driven and patient-centric trials.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement