Benefits of doing Clinical Trials in CEE

In Central and Eastern Europe (CEE) approximately 1,000 new studies are registered annually. Hungary and the Czech Republic take the largest share of this, with 250 – 300 clinical trial registrations per year in each.

Although there are fewer trials registered in Russia each year, Russia remains an important destination because of its wealth of sites and patients.

The CEE is one of the most dynamic and fastest-growing regions in Europe, and there are several advantages to placing clinical research studies in these areas, including:

 

(1) RAPID RECRUITMENT OF STUDY POPULATION

Numerous multinational clinical trials have demonstrated that the patient recruitment rate in CEE countries is significantly higher than in Western Europe or in the USA. Why?

  • CEE Investigators are motivated to take part in Clinical Trials
  • Naive (untreated) patient populations are widely available
  • CEE patients trust – and seek out –  physicians and Western medicines
  • The unique centralized healthcare systems of the CEE concentrate large numbers of patients in a few, easy to reach locations
  • CEE regulatory bodies are supportive of studies in general

 

(2) INVESTIGATORS ARE HIGHLY MOTIVATED AND LOYAL

Unlike their western counterparts, physicians in the CEE seek out and support clinical studies for many reasons, making them ideal partners for western sponsors.  Why?

  • Lower salaries in the region’s healthcare sector means that investigator fees can be important sources of extra income for CEE physicians.
  • Co-operating with US / EU companies in scientific research is a sign of merit — it is well known that only the best candidates are selected.
  • The number of teaching hospitals, university clinics and postgraduate medical schools is high. More practitioners are employed by teaching hospitals and university clinics than in Western Europe.
  • Physicians actively seek the best treatments for their patients, and studies are often the best answer.

 

(3) REMARKABLE PRICE ADVANTAGE

Where can your study enjoy the advantages of a first-world infrastructure with the cost savings of a developing country? The CEE has many opportunities to magnify the impact of your clinical budget. How?

  • Investigator and site fees in the CEE are 25% to 30% lower than those in the U.S. or Western Europe.
  • Monitoring costs are also 25% to 30% less than similar services in the USA.
  • Almost all aspects of your study will be significantly less expensive, including real budget-killers like travel, accommodation and postage.

 

(4) LOCAL MONITORS ARE MORE SKILLED THAN AVERAGE

Without a doubt, around the world you will find that the professionals in pharma research are among the most highly educated and well-trained people. In the CEE, however, this tends to be even truer because of the unique social and economic dynamics here. Why?

  • Because of the many opportunities in clinical research, more and more physicians and pharmacists are working as CRAs or Project Managers.
  • The highly regarded academic and industrial training programs of the CEE region produce a valuable human resource pool for all types of research professionals.

 

(5) Excellent FDA Audit results in CEE

The graph below speaks for itself. The CEE leads the world in its ratio of highly successful audits by the FDA. And we have done it without any Official Actions Indicated!

Case Study

Enrollment overachieved in rescue project. In 2010, a US-based biotech company contacted HungaroTrial for a rescue project. The study had started in the US, but enrollment figures were far below the planned rate. Since the indication was a rare disease and patient selection criteria were very limiting, it proved to be extremely difficult to find suitable trial sites and subjects. HungaroTrial set up the project in Hungary very quickly, within three months, and went on to enroll 26 patients instead of the contracted 18 – a 144% overachievement in patient recruitment. Data quality was well maintained by the involvement of HungaroTrial’s QA Department.

Quality in CEE

FDA inspections reveal CEE excellence in data quality. An analysis of the FDA's inspection database shows that the CEE region has the highest percentage of inspections concluded with the outcome "No Action Indicated" (NAI). Furthermore, not a single inspection in the region ended with an "Official Action Indicated" (OAI) conclusion. These results are not only comparable with inspections carried out in Western Europe, but are even better.


Copyright: HungaroTrial 2014