Country trial regulations follow the principles of the Declaration of Helsinki and the guidelines of the International Conference on Harmonization (ICH). Local legislation is harmonized with EU directives and GCP rules. GCP was implemented as a law in 1999.
- realistic start-up time: 4.5 – 6 months
For the last couple of years there were conducted about 180 studies mainly in oncology, cardiology and diabetes. Due to vertical referral system (local outpatient clinics and other consulting physicians), investigators can recruit patients (mainly treatment-naïve) from the regional population without any competition inside.
Patients are compliant, motivated and willing to participate in clinical trials to have access to novel therapies which are not yet available or not reimbursed by the Belarusian healthcare system.
Cardiovascular diseases and cancer are the leading causes of mortality in Belarus. Estimated deaths per 100,000 population by cause (higher than world or European average):
|Diseases||Belarus||World Average||Europe Average|
|Mental and substance use disorders||25.3||4.3||11.1|
|Infectious and parasitic diseases||21.1||77.7||19.3|
Data from World Health Organization
Investigators and Sites
Belarus has a centralized healthcare system with over 600 public hospitals (including medical university clinics and institutes, and 800 outpatient clinics, with over 80 accredited clinical study sites. Belarus has very high hospital beds’ density: 112 beds/10,000 population (for comparison, there are 83 hospital beds per 10 000 population in Germany; and 97 in Russia).
Main types of medical facilities are general hospitals and specialized clinics (located in all major towns and cities), polyclinics and first-aid stations offering medical care to the people in the rural areas.
There are approximately 5,000 physicians in Belarus. They are highly educated and motivated, ICH GCP experienced, and deliver very high recruitment and quality data. They speak English at an intermediate or advanced level. Doctors salaries are extremely low:around US$ 600 per month, on average.