The life of an average medicinal product before it appears on the drug store shelves consists of several cycles, which include such as molecule elaboration and drug discovery, API formulation, pre-clinical tests, clinical studies, market authorization, post-marketing authorization and research. This is a rough picture of the drug development process. More than 1,5 bln dollars may be spent for the process of a new drug development and its approval. Almost ½ of the investment allocated for this development comprise clinical trials programs. It takes 10-15 years to fully develop a medication and introduce it to the market. Out of 5.000 new molecules, only several may proceed with the whole way from its discovery till marketing authorization.
Pharmaceutical and biotechnology industries are among the five leaders, which allocate impressive amount of resources and funds into R&D (along with electronics, computers and software, informational technologies, automobile industry). For instance, in the USA its ratio is about 20%, in the countries of the European Union – about 15%, in Japan – around 7%, in other countries – about 25%.
USA and some Asian countries are the leaders in the industry of new drugs. Till the recent times, more innovations were made in those parts of the world, whereas more generic businesses, marketing activities were dominating in Europe.
Clinical trials in Eastern Europe represent quite a unique subsector of the worldwide clinical trials market. The recent 5-7 years have seen an increase in the number of studies along with the ever rising quality of the performance and the results. Now, great perspectives are being opened to Europe, too. There is yet a certain discrepancy: in Western European countries certain limitations exist – slow enrollment in some cases, high costs of the trials, limited number of clinical sites or their overload. In this situation, Eastern European countries offer an alternative including lower prices of clinical studies conduct, more motivated investigators, quick recruitment of patients/volunteers, good qualified centers with development perspectives. As a consequence, more companies are coming to this region.
OCT countries of operation, which include Russia, Ukraine, Belarus, Latvia, Bulgaria, Lithuania, Estonia, represent some of the leading markets in Eastern Europe.
Countries in Central and Eastern Europe offer clients a number of benefits, including
Quick enrollment
- Big Patient population
|
Russia |
142,905,208 |
|
Ukraine |
45,888,000 |
|
Belarus |
9,503,807 |
|
Bulgaria |
7,364,570 |
|
Latvia |
2,245,357 |
|
Lithuania |
3,210,761 |
|
Estonia |
1,340,194 |
The total population of the region exceeds 200 million people. We believe that OCT geographical presence is a strategic advantage; in addition to having access to a large population, it is also a population that is drug naive in several therapeutic areas, at least they have not been exposed to many new western drugs, and disease prevalence is similar to other European countries and is higher in some indications. This translates into some key advantages for placing clinical trials in these territories, including fast recruitment, yet offering the potential for significant cost savings.
This region will continue to develop and grow in the future, with more companies placing big phase II-III clinical trials. There is a long way to go before a saturation point is reached.
- Easy to target patient populations
Large patient populations are easily accessible due to organized, centralized healthcare centers. The population in Russia, Ukraine, Belarus, Latvia, Lithuania, Estonia and Bulgaria is concentrated in the biggest cities.
- Big urban population
The population is concentrated in the main cities:
| Country | city | Population | % of total population of the country |
| Russia | Moscow | 11 800 992 | 8,3% |
| Russia | Saint Petersburg | 4 900 520 | 3,4% |
| Russia | Novosibirsk | 1 397 191 | 1,0% |
| Russia | Yekaterinburg | 1 332 264 | 0,9% |
| Russia | Nizhny Novgorod | 1 272 527 | 0,9% |
| Russia | Samara | 1 164 900 | 0,8% |
| Russia | Kazan | 1 143 600 | 0,8% |
| Russia | Omsk | 1 129 120 | 0,8% |
| Russia | Chelyabinsk | 1 093 699 | 0,8% |
| Russia | Rostov-on-Don | 1 048 991 | 0,7% |
| Russia | Ufa | 1 024 842 | 0,7% |
| Russia | Volgograd | 1 021 200 | 0,7% |
| Russia | Perm | 985 794 | 0,7% |
| Russia | Krasnoyarsk | 947 801 | 0,7% |
| Russia | Voronezh | 843 496 | 0,6% |
| Russia | Saratov | 830 953 | 0,6% |
| Russia | Tolyatti | 720 346 | 0,5% |
| Russia | Krasnodar | 710 686 | 0,5% |
| Russia | Izhevsk | 611 043 | 0,4% |
| Russia | Yaroslavl | 606 336 | 0,4% |
| Ukraine | Kiev | 2,765,500 | 6% |
| Ukraine | Kharkiv | 1,440,676 | 3% |
| Ukraine | Dnipropetrovsk | 1,006,276 | 2% |
| Ukraine | Odessa | 1,005,591 | 2% |
| Ukraine | Donetsk | 977,257 | 2% |
| Ukraine | Zaporizhia | 776,918 | 2% |
| Ukraine | Lviv | 758,351 | 2% |
| Ukraine | Kryvyi Rih | 670,068 | 1% |
| Ukraine | Mykolaiv | 499,659 | 1% |
| Ukraine | Mariupol | 489,702 | 1% |
| Ukraine | Luhansk | 470,152 | 1% |
| Ukraine | Makiivka | 398,058 | 1% |
| Ukraine | Vinnytsia | 369,200 | 1% |
| Ukraine | Simferopol | 359,551 | 1% |
| Ukraine | Sevastopol | 380,301 | 1% |
| Ukraine | Kherson | 340,525 | 1% |
| Ukraine | Poltava | 298,492 | 1% |
| Ukraine | Chernihiv | 296,896 | 1% |
| Ukraine | Cherkasy | 287,591 | 1% |
| Ukraine | Sumy | 272,899 | 1% |
| Belarus | Minsk | 1,836,808 | 19% |
| Belarus | Gomel | 481,000 | 5% |
| Latvia | Riga | 706,413 | 31% |
| Latvia | Liepāja | 301,621 | 13% |
| Lithuania | Vilnius | 560 190 | 17% |
| Lithuania | Kaunas | 321,200 | 10% |
| Estonia | Tallin | 414,752 | 31% |
| Estonia | Tartu | 101,169 | 7,5% |
About 25 % of Russian population is concentrated in 20 biggest Russian cities. Population is densest in European Russia, near the Ural Mountains, and in southwest Siberia. 32 % of Ukrainian population is concentrated in 20 biggest Ukrainian cities. About 25% of Belarusian population is based in 2 biggest cities of Republic of Belarus. 2 main Latvian cities account for about 44% of total population. 27 % of Lithuanian population is based in 2 biggest cities. Estonian capital accounts for 31 % of total population of Estonia. This means that it is not necessary to open many sites in different cities; it is enough to open sites in the biggest cities, which translates into low logistics costs.
- Centralized healthcare system
Centralized healthcare system with developed referral network has an important role in patients’ recruitment into clinical trials in Central and Eastern Europe. Big patient populations are concentrated in big regional, city and republican hospitals, thus sites in Russia, Ukraine, Belarus, Latvia, Lithuania, Estonia and Bulgaria can easily enroll difficult to target patients.
- Motivated patients
- Patients willing to be treated
Patients in Central and Eastern Europe are highly motivated to participate in clinical trials because they can benefit from new drugs; procedures and a better medical care.
- Educated patients
Widespread and in-depth educational system has produced nearly 100% literacy in Russia, Central and Eastern Europe. This results in patients’ understanding of clinical research and informed consent form.
- Drug naive patients
Patients in Central and Eastern Europe have not been exposed to many drugs available in the USA and Western Europe. Thus there are more patients that can meet inclusion criteria of many protocols.
- Motivated investigators
- Additional income for doctors
Doctors’ salaries are comparatively low in Russia, Ukraine, Belarus, Latvia, Lithuania, Estonia and Bulgaria, so participation in clinical trials brings substantial income to physicians.
- Other benefits for doctors
Participation in clinical trials provides physicians with the latest therapies allowing doctors to treat patients with products not yet widely available in the country. It also offers opportunities for scientific publications, education and travel. Added to this there is also a certain element of gaining recognition for the physicians and sites.
- Good relationship between doctors and patients
People in CEE have good respect for doctors. Patients fully rely on doctors because “doctor knows best”. This results in good patients compliance.
Good quality data
The culture of clinical research is very high in Russia, Central and Eastern Europe. This is supported b the fact that data generated in Russia, Ukraine, Belarus, Latvia, Lithuania, Estonia and Bulgaria have been accepted in regulatory submissions in FDA and EMEA. FDA inspections in the region did not detect major findings.
Stable Regulatory environment
Most of the countries in CEE are now part of the European Union and follow the EU Directive on clinical trials. For EU countries, there is a core set of documents required for all submissions and a common application form for both regulatory and ethics submissions. Those that are not yet part of the EU, such as Russia, Ukraine and Belarus, have legislation regulating the conduct of clinical trials which are already set in the country. The regulations comply with ICG GCP.
In general, we would expect to have regulatory and ethics responses within 60 days of submission in countries like Latvia, Lithuania, Estonia and Bulgaria. In Russia, Ukraine and Belarus it might take up to 90 days.
Availability of good vendors in Central and Eastern Europe
There is a good choice of Central Laboratories and Depots in Central and Eastern Europe.
Cost effective clinical trials
- Lower Investigator’s grants
Historically the costs associated with clinical trials are lower in Russia and CEE. Salaries paid to physicians cannot be compared with those in the USA and Western Europe. Thus, fees paid to investigators and hospitals are comparably lower than in western countries. Principal investigators grants usually account for the biggest part of clinical trial budget, so in Russia, Ukraine, Belarus, Latvia, Lithuania, Estonia and Bulgaria pharmaceutical countries can find potential for costs saving.
- Lower clinical trials procedures cost
The cost of procedures (CT scan, X-ray, ECG, etc.) is also less expensive in Central and Eastern Europe.
- Lower CRO services costs
CRO staff hourly rate in Central and Eastern Europe is much lower than in the USA and Western Europe. It results in lower CRO services budgets.
Well educated CRO staff
Project Managers and CRAs usually have a medical degree or medical background which enables us to see Investigators’ mistakes in advance.