Approval Process
Romania, although a new member of European Union, has many years of experience in conducting clinical trials. The legislation on clinical trials is harmonized with the EU and the EU Clinical Trials Directive was transposed into national legislation in 2004.
- realistic start-up time: 5.5 months
Recruitment Potential
As the fourth most populated European country it offers a significant pool of motivated, compliant and mostly treatment-naïve subjects, especially in:
- infectious diseases – prevalence of hepatitis B in Romania is one of the highest rates in Europe
- cancers – the highest incidence of cervical cancer in Europe
- cardiovascular and respiratory disorders
- diabetes – there are 800,000 patients registered and at least 600,000 have diabetic neuropathy; less than 50% of patients are being treated
Estimated deaths per 100,000 population by cause (higher than world/European average):
| Diseases | Romania | World Average | Europe Average |
|---|---|---|---|
| Cardiovascular diseases | 753.7 | 240.9 | 465.2 |
| Neoplasms | 236.0 | 222.1 | 236.2 |
| Digestive diseases | 82.8 | 32.0 | 30.9 |
| Genitourinary diseases | 25.1 | 18.8 | 20.1 |
| Mental and substance use disorders | 6.4 | 4.3 | 11.1 |
Data from World Health Organization
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.
Investigators and Sites
There are approximately 460 sites in Romania, including over 50 private and public sites located in Bucharest. The Romanian investigators are appropriately qualified by education, training and experience. They are ICH GCP experienced, highly motivated and deliver very high quality data. Majority of the Romanian CRAs are physicians, biologists or nurses, which leads to excellent relations with the investigators and excellent quality and understanding of the data.