Approval Process
Serbia is not a European Union member and still has its own, specific legislation requirements.
- realistic start-up time: 4.5 months
Recruitment Potential
During the last decade, the number of clinical trials in Balkan countries, including Serbia, significantly increased. Patients (mostly treatment-naïve) are willing to participate in clinical trials to have the possibility for treatment with novel therapies which are not yet available or not reimbursed by the Serbian healthcare system.
Estimated deaths per 100,000 population by cause (higher than world/European average):
| Diseases | Serbia | World Average | Europe Average |
|---|---|---|---|
| Cardiovascular Disease | 881.9 | 240.9 | 465.2 |
| Neoplasms | 349.3 | 222.1 | 236.2 |
| Respiratory Diseases | 65.3 | 53.3 | 48.8 |
| Digestive Diseases | 59.6 | 32.0 | 30.9 |
| Diabetes Mellitus | 51.1 | 21.6 | 19.4 |
| Genitourinary Diseases | 38.3 | 18.8 | 20.1 |
| Neurological Conditions | 34.1 | 27.4 | 59.5 |
| Mental and substance use disorders | 7.1 | 4.3 | 11.1 |
| Musculoskeletal diseases | 2.8 | 2.1 | 2.8 |
Data from World Health Organization
The highest burden of disease in Serbia is due to:
- cardiovascular disease (responsible for 55% of mortality) – a high prevalence of risk-factors such as tobacco smoking (33% of adult population over 20 smoke) and growing obesity among adults and children.
- cancer (responsible for 20% of mortality)- the second biggest killer responsible for more than 20 000 deaths annually. The mortality for preventable cancer is of concern, especially for:
- cervical cancer (incidence three times higher than the EU average),
- breast cancer (incidence higher than the EU average)
- and growing lung cancer especially among women
Investigators and Sites
There are 43 well equipped and experienced university hospitals in Serbia, including 17 ones located in Belgrade. Serbian investigators are familiar with ICH GCP, highly motivated and deliver high quality data within the required timelines.
The healthcare system in Serbia is centralized creating an important advantage for clinical trial recruitment due to high concentration of patients in large medical centers.