Approval Process
Estonia is the smallest of the three Baltic countries. After joining the European Union in 2004, Estonia harmonized the legislation on clinical trials with the EU, implemented Directives into the local regulations, and also started to follow the applicable EU guidelines.
- realistic start-up time: 3.5 months
Recruitment Potential
A great advantage for clinical research in Estonia is the easy access to a broad group of patients who have not yet been treated with modern therapies, mainly due to economical constraints. Therefore, large groups of treatment-naïve patients are available for all major therapeutic areas.
Estimated deaths per 100,000 population by cause (higher than world/European average):
| Diseases | Estonia | World Average | Europe Average |
|---|---|---|---|
| Cardiovascular Disease | 653.2 | 240.9 | 465.2 |
| Neoplasms | 277.8 | 222.1 | 236.2 |
| Digestive Diseases | 45.1 | 32.0 | 30.9 |
| Mental and substance use disorders | 22.5 | 4.3 | 11.1 |
| Genitourinary diseases | 22.5 | 18.8 | 20.1 |
Data from World Health Organization
Estonia is ranked among the top 3 countries in the world in terms of kidney and ovarian cancer incidence, and has one of the highest incidence rates in leukemia, kidney and lung cancer in the EU.
Estonia is one of the smallest countries in the European region and it usually cannot deliver huge numbers of patients for the study (i.e. Phase III), on its own. But it is an excellent place to have your “first patient in” due to relatively short start-up period.
Investigators and Sites
There are approximately 80 sites in Estonia, mainly public hospitals (including medical university hospitals) and outpatient clinics. Usually, sites are properly equipped, conducting therapeutic and diagnostic procedures according to the European standard of care.
Investigators are ICH GCP experienced, well educated, motivated and deliver high quality data.