GCT has solid experience in Gastroenterology field (see some examples in the table below). We effectively managed numerous trials in Ulcerative Colitis, Duodenal Ulcers, and performed multiple feasibility studies for Crohn’s disease, chronic Pancreatitis, and others. It helps us maintain unique relations in Russian gastroenterological community with direct access to all major KOLs.
| Phase | # Pnts | # Sites | Countries | Indication | Sponsor |
|---|---|---|---|---|---|
| TE / III registration study | 338 | 20 | Russia | Ulcer trial | US Pharma |
| III | 370 | 12 | Russia | Duodenal Ulcers | US Pharma |
| III | 380 | 46 | Russia, Ukraine | Ulcerative Colitis | US Pharma |
| II | 10 | 5 | Russia, Other | Ulcerative Colitis | UK Leading Biopharma |
| III (incl. preclinical study in Russia) | 336 | 29 | Russia, Ukraine | functional intestinal symptoms | EU Pharma |
| IIa | 21 | 5 | Russia | Ulcerative Colitis | Israeli Biotech |
Inflammatory bowel disease
In Europe alone more than 3 million people are estimated to be affected by IBD. However, the classic geographical distribution of the diseases is changing as traditionally low incident regions like Eastern Europe have recently reported rising in incidence rates. An increase in disease awareness, improved access to healthcare and diagnostic procedures, or true changes in life style and environmental factors as a consequence of the socio-economic transition from developing to developed in many Eastern European countries could all account for some of the changes.
According to US Census Bureau, International Data Base, extrapolated prevalence of IBD in Romania is 44,071; in Bulgaria – 15,035; Russia has 287,948 prevalence and Ukraine – 95,464.
The same US Census Bureau statistics evaluate prevalence of the principal type of IBD – Crohn’s disease as following: Romania – 41,094, Bulgaria – 13,819, Russia – 264,658, and Ukraine – 87,742.
Ulcerative Colitis is another type of IBD. The incidence of Ulcerative Colitis in Russia, for example, the prevalence is 895 per 100 000.
Ukraine
According to WHO, in Ukraine Gastrointestinal diseases in the structure of all diseases occupy third place (9.3%), and in the structure of morbidity – 7th (4.2%). Every year there is a clear tendency of increase in these figures. From 1994 to 2006, the number of gastroenterological patients in Ukraine increased from 4.6 to 6.3 million patients, which is almost 1.4 times more. The incidence of gastroduodenitis during this period showed growth by 39.5%, hepatobiliary system disorders – 29.5%, and pancreas disorders by 10.1%.
Russia
According to the Statistical materials of the Ministry of Health of the Russian Federation, Department of Analysis, Forecasting, development of health and medical science there were 17,358,957 reported cases of the digestive system diseases in 2014.
Peptic Ulcer Disease and Chronic pancreatitis in Russia
According to the Statistical materials by MOH RF, 2014, in Russia not less than 9% of the population suffer from UD (7-10% is a global trend). More than 3 million patients are under dispensary observation. The upward trend in the number of patients with complicated UD is being observed. More than 6,000 people die of UD complications every year.
Russia has seen a dramatic increase in the incidence of Chronic Pancreatitis. Prevalence of chronic pancreatitis in children is 9-25 cases, and among adults – 27-50 cases per 100,000 population. From more than 60,000 patients with CP 11% go on disability and 30% of patients have early complications (the mortality is 5.1%).
More information
We will be happy to provide more information about Gastroenterology studies in CEE and Russia. Please contact us or simply use the form below. A representative will respond shortly.
