Approval Process
Georgia has relatively short timelines for study approval procedure.
- realistic start-up time: 2.5 – 3 months (the shortest approval timeline in Europe)
Recruitment Potential
At present, over 230 studies have been registered under the official clinical trial registry in Georgia (41% in cardiovascular diseases, 37 % in oncology, 12% in neurology and 10 % in other therapeutic areas).
Cancer with its frequency and spread keeps one of the first places in the structure of mortality in Georgia. Over 33,000 (prevalence) cancer patients are registered in Georgia. Every year approximately 7,000 (incidence) new cases of malignant tumors are diagnosed, including 200 children. The most common are: lung (24%), colorectal (9%) and prostate (8%) cancer in men and breast (36%), cervical (9%) and uterine (8%) cancer in women.
Patients (mostly treatment-naïve) are generally compliant and willing to participate in clinical trials due to limited access to novel therapies.
Estimated deaths per 100,000 population by cause (higher than world/European average):
| Diseases | Georgia | World Average | Europe Average |
|---|---|---|---|
| Cardiovascular diseases | 743.5 | 240.9 | 465.2 |
| Respiratory diseases | 54.1 | 53.3 | 48.8 |
| Neurological conditions | 44.7 | 27.4 | 59.5 |
| Digestive diseases | 40.0 | 32.0 | 30.9 |
| Diabetes mellitus | 23.5 | 21.6 | 19.4 |
| Neonatal conditions | 11.8 | 31.5 | 6.0 |
| Congenital anomalies | 7.1 | 8.8 | 4.6 |
Data from World Health Organization
Investigators and Sites
Academic centers and specialized hospitals for all therapeutic areas and experienced investigators provide excellent patient recruitment and retention.
The majority of sites are located in the largest cities, for example the National Cancer Center with 5 regional oncology dispensaries.
Tbilisi, the capital, has the largest and most modern specialist hospitals for all therapeutic areas. Sites and PIs specialized in cardiovascular diseases are considered the most experienced ones.