Czech Republic is one of the Central European countries with a population of 10.65 mil. inhabitants. The other Central European countries are Poland, Slovakia and Hungary (possessing together with the Czech Republic a population of more than 64 million people). Many economical, health care, and clinical research characteristics are similar in all these countries.
However back to the Czech Republic: It’s a member of the European Union since 2004 and according to the Euro Health Consumer Index, there are highly accessible healthcare services. The legislation is fully harmonized with the European Union and specialists from the State Institute for Drug Control (the Czech Regulatory Authority) are active members of many EMA working groups. There is also very traditional network of University Hospitals including highly specialized centers of care for e.g. oncological, cardiological or rheumatological patients. Beside this network, we can see a rapid growth of privately-owned very well-equipped high-quality healthcare facilities, frequently also focused on providing clinical trials.
All together there are over 800 clinical trial sites in the Czech Republic, both public and private hospitals and clinics. At these sites, you can find well educated investigators, regularlytrained in ICH GCP, highly motivated and delivering both recruitment targets and very high-quality data; many of these sites are also featuring Clinical Trial Coordinators.
Let numbers speak for a while:
- Currently (September 2019), there are 1319 actively running clinical trials (not including trials on medical devices) in the Czech Rep.
- In 2018, there were 366 new clinical trials submitted to the regulatory authority (excluding medical devices), out of it:
– Phase I: 19 trials
– Phase II: 90 trials
– Phase III: 214 trials
– Phase IV: 17 trials
– Bioequivalence: 26 trials
- Approval timelines are: 10 weeks for regulatory authority including the CTA Validation; 8 weeks for Multicenter/Local Ethics Committees; both Applications can be submitted in parallel. The Czech Regulatory Authority is also regularly participating in VHP assessments.
And some typical questions about our region:
- Is the site staff fluent in English? Yes. Investigators and Clinical Trial Coordinators always; nurses in the big hospitals also. Generally, there isn’t a single site where the communication in English would be a problem.
- Is it a very cheap region? No. One shouldn’t expect extremely low costs. Central Europe nowadays shows excellent recruitment rates and high-quality data not for the cheapest price worldwide, but for the best cost benefit ratio worldwide.
- Is everything applicable also for Medical Devices studies? Yes. With some small differences in regulatory and ethical approval processes, the environment for these studies is also very favorable in the Czech Republic and the Clinical Investigations are emerging market in our region. Czech Republic is well prepared for MDR and the new ISO 14155.
So why choose the Czech Republic for conducting the clinical trial?
- Because of high density of very skilled sites with fully trained staff, excellent equipment and frequently with Clinical Trial Coordinators.
- Because of transparent and professional regulatory environment.
- And because of excellent cost benefit ratio.