Approval Process
The interest in performing clinical trials in Bulgaria continues to grow. Bulgaria became a member of the European Union (EU) in January 2007. After that the legislation and the Drug Law were changed to abide by EU legislation.
- realistic start-up time: 4 – 4.5 months
Recruitment Potential
Large, often treatment-naïve, patient populations are readily available due to the centralized healthcare system (7,36 million population of Bulgaria and 1,4 million in Sofia, the capital, where the major specialized clinics and university hospitals are located). Bulgaria has one of the highest incidence rates in cervical and ovarian cancer in the European Union.
Estimated deaths per 100,000 population by cause (higher than world/European average):
| Diseases | Bulgaria | World Average | Europe Average |
|---|---|---|---|
| Cardiovascular Disease | 968.0 | 240.9 | 465.2 |
| Neoplasms | 255.1 | 222.1 | 236.2 |
| Neurological conditions | 59.4 | 27.4 | 59.5 |
| Respiratory diseases | 52.7 | 53.3 | 48.8 |
| Digestive diseases | 44.6 | 32.0 | 30.9 |
| Diabetes Mellitus | 27.0 | 21.6 | 19.4 |
| Genitourinary Diseases | 21.6 | 18.8 | 20.1 |
Data from World Health Organization
Bulgarian patients are motivated to participate in clinical trials because of the opportunity to access effective drug therapy, reduced treatment costs, closer medical follow up and significantly better overall medical care. The level of treatment compliance is high, because of the exceptionally trusting patient-doctor relationship.
Investigators and Sites
There are approximately 100 sites in Bulgaria, with 20 sites located in Sofia. The Bulgarian investigators are appropriately qualified by education, training and experience. They are ICH GCP experienced, highly motivated and deliver very high quality data. Most of the Bulgarian CRAs are physicians, pharmacists, biologists or nurses, which leads to excellent relations with the investigators and excellent quality of the data.