Today we will take a deeper look into Clinical Trials in Central Europe by interviewing Dr. Jiří Paseka, an expert in Clinical Studies in Visegrád Group (Czech Republic, Slovakia, Hungary and Poland).
With a population of over 64 million people, Central Europe has become an interesting target for medical companies looking to test their products: nowadays, the quality of clinical trials executed by General Practitioners has improved dramatically and, all the while, there are a huge number of private clinics (very well-equipped), a number that is continuously increasing.
-How much experience can we expect from a Central European researcher?
Although continuous good clinical practice trainings for all the investigators and refresher courses on a regular basis is mandatory in other European countries, there is no country regulation for the education of the investigators in Central Europe. There is, however, a general requirement to pass the Good Clinical Practice training before starting any clinical trial and refresh it every two years.
Communication is very easy in central Europe, as everyone, from Study Nurses to Trial Coordinators speak English fluently. In the Czech Republic alone you’ll find over 800 fully-trained Good Clinical Practice sites, both in public and private hospitals.
–Is the Czech Republic a good place for Medical Device manufacturers to run studies?
It absolutely is. They started with the Medical Device trials even before the new Medical Device Regulation was published and their activities are equally distributed between pharmaceuticals and device clinical trials.
-What kind of patients can Central Europe provide?
Investigators shouldn’t worry about the conditions that are connected to less developed healthcare systems when considering Central Europe. Nowadays, the distribution of trials in Central Europe is very similar to Western Europe, particularly in Oncology and Cardiology.
-Let’s discuss Regulatory Backgrounds in Central Europe
In all Central European countries, the legislation concerning Clinical Trials is fully harmonized with the European Union. Also, there is a Regulatory Authority in each of the countries.
–Is Central Europe ready to processes of contract negotiation?
In these countries, contract negotiations are easier in private facilities. On the other hand, at public hospitals, the negotiations could last up to two months or even longer, because some parts of the contracts are hardly negotiable.
What can sponsors who want to run clinical studies in Central Europe expect?
Central Europe is no longer an under-developed region, so you must be aware that the salaries have increased in later years. On the other hand, you can expect proven recruitment records, high quality data and one of the best cost/effectiveness ratio worldwide.
These benefits, coupled with reasonable costs, make Central Eastern Europe a very attractive place for execution of Clinical Trials, especially for small to mid-sized manufacturers of both medical devices and pharmaceuticals.