Approval Process
Slovenia is a member of the European Union and EU directives are incorporated into its legislation. At a national level there is only one Ethics Committee: the National Medical Ethics Committee (NMEC). NMEC is the main body responsible for biomedical research ethics in the country. There are also two regional Ethics Committees in Maribor and Celje, however they are not authorized to grant independent approvals.
- realistic start-up time: 4 – 5 months
Recruitment Potential
There are approximately 30 new trials registered in Slovenia each year. Due to the small size of the country, Slovene physicians and other medical staff, as well as patients, are exceedingly motivated to collaborate with foreign sponsors in order to get the access to novel and expensive therapies.
Slovenia is at the top among the EU countries with regards to incidence of colorectal and gastric cancer, as well as other gastrointestinal diseases.
Estimated deaths per 100,000 population by cause (higher than world/European average):
| Diseases | Slovenia | World Average | Europe Average |
|---|---|---|---|
| Cardiovascular Diseases | 355.8 | 240.9 | 465.2 |
| Neoplasms | 287.5 | 222.1 | 236.2 |
| Digestive Diseases | 58.5 | 32.0 | 30.9 |
| Unintentional Injuries | 48.7 | 48.0 | 40.4 |
| Respiratory Infections | 29.2 | 43.6 | 28.9 |
| Musculoskeletal Diseases | 4.9 | 2.1 | 2.8 |
| Mental and substance use disorders | 4.9 | 4.3 | 11.1 |
Data from World Health Organization
Slovenia is one of the smallest countries in the European region and it usually cannot deliver huge number 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
Slovenia has a network of public and private healthcare providers at a primary, secondary and tertiary level. Healthcare is financed from public and private sources (compulsory and voluntary health insurance) and from direct payments. There are approximately 30 hospitals in Slovenia, with two large Medical Centers in Ljubljana and Maribor, comprising special departments and institutes. Health institutions are adequately equipped and have highly qualified, experienced staff. Investigators are experienced in clinical research, fluent in English and familiar with ICH GCP guidelines.