Approval Process
Approval for clinical trial is issued by the Medicines and Medical Devices Agency of Bosnia and Herzegovina and it is in accordance with EU directives 2001/20/EC and 25/2008/EC.
- realistic start-up time: 4 – 4.5 months
Recruitment Potential
There are approximately 15 new trials registered in Bosnia and Herzegovina each year. In this almost 4 million population country there are large groups of treatment-naïve patients eager to participate in clinical trials in order to receive novel treatment. Well established patient referral network enables high and rapid recruitment, especially with regards to cancer and cardiovascular diseases.
Estimated deaths per 100,000 population by cause (higher than world/European average):
| Diseases | Bosnia and Herzegovina | World Average | Europe Average |
|---|---|---|---|
| Cardiovascular Disease | 513.70 | 240.90 | 465.20 |
| Diabetes mellitus | 54.80 | 21.60 | 19.44 |
| Mental and substance use disorders | 5.20 | 4.30 | 11.10 |
| Neurological conditions | 49.50 | 27.40 | 59.50 |
Data from World Health Organization
Investigators and Sites
The healthcare system in Bosnia and Herzegovina is decentralized. Ministry of Health and ten separate health departments are responsible for healthcare in each of the cantons.
There are four types of hospitals: Clinical / University Centers (Sarajevo, Banja Luka, Mostar and Tuzla), General Hospitals, Specialized Hospitals and District Hospitals. General Hospitals usually have four departments: internal medicine, surgery, pediatric care, and gynecology. Apart from caring for inpatients, hospital doctors also provide consultancies to outpatients who are referred to them by a GP.
Investigators have high quality performance and are highly motivated for participating in clinical trials.