Approval Process
Clinical trials in Ukraine are conducted in accordance with ICH-GCP requirements, despite the fact that it is not a member of the EU.
- realistic start-up time: 3 – 4 months
Recruitment Potential
Ukraine represents the second largest patient pool in Europe that makes recruiting patients easier and faster. Healthcare system is centralized and structured around big hospitals and encompasses a large population. Due to vertical referral system, investigators can recruit patients (mainly treatment-naïve) from the regional population without any competition inside.
A large number of pediatric trials have been conducted over last years in Ukraine. Around 20% of this population is represented by children under 16 years old. The centralized system of pediatric healthcare, with a high concentration of children in academic pediatric centers and specialized children hospitals, creates an ideal environment for recruitment into clinical trials.
Estimated deaths per 100,000 population by cause (higher than world/European average):
| Diseases | Ukraine | World Average | Europe Average |
|---|---|---|---|
| Cardiovascular Diseases | 1,125.2 | 240.9 | 465.2 |
| Neoplasms | 200.7 | 222.1 | 236.2 |
| Unintentional Injuries | 69.7 | 48.0 | 40.4 |
| Infectious and Parasitic Diseases | 60.7 | 77.7 | 19.3 |
| Respiratory Diseases | 32.53 | 21.46 | 35.89 |
| Mental and substance use disorders | 23.7 | 4.3 | 11.1 |
Data from World Health Organization
Investigators and Sites
Ukraine has a centralized healthcare system with an extensive number of public hospitals (including 18 university medical faculties) and outpatient clinics. There are approximately 5 doctors and 10 hospital beds for every thousand people, which is enough not only by developing country but also by Western European standards.
Private medical sector is present only in the large cities and it is accessible to the very narrow section of the population.
Ukrainian investigators are ICH GCP experienced, well educated, motivated and deliver very high recruitment and quality data.