Traditionally, industry-sponsored clinical research used to be situated in relatively safe regions like North America, Western Europe or Oceania. In recent years, however, the biopharma-sponsored clinical evaluations of drugs are being gradually moved to the so-called emerging regions, such as Eastern Europe, Latin America and Asian countries. The reasons for such transition include the outlook of the reduction of operational costs while recruiting a large number of patients in a timely manner; the establishment of contract research organizations focused in global clinical trials; the rapid pace of growth of market size, research capacity and regulatory authority in emerging regions; and the harmonization of guidelines for clinical practice and research. The number of clinical trials initiated in Central and Eastern Europe more than tripled from 2002 to 2007, making the region a key part of global clinical research.

The 2008 estimate of the European clinical trials market was €20.3 bln ($32 bln). It is reasonable to expect a 10.6% annual growth, which would lead to 30.38 bln ($47 bln) in 2012. Eastern Europe constitutes a large portion of this growth. Some 65% of clinical trials are directly managed by pharmaceutical companies, whilst CROs account for most of the remaining 35%.

Many of the major CROs are U.S.-based, there were 269 CROs in the U.S., and 462 more in Europe. Quintiles is the market leader, with 14% of the global market share; followed by Covance and PPD, holding 10% each. The five largest CROs have increased their market share and now hold 45% of the total market.

The growth drivers for clinical trials in CEE are greater access to drug-naïve patients, lower labor costs and other site fees, higher concentration of patients near sites, and closer relationships between doctors and patients. All this creates a typical dropout rate of less than 5% compared to 20% in Western Europe. This means that the initial investment to start a trial, such as the submission fees to ethics committees, give access to a much higher number of potential subjects suitable for the trial than in Western Europe—consequently, CEE offers more subjects per Euro spent. In terms of growth, our understanding is that CEE is growing at about twice the rate of Western Europe—some companies interviewed use 30% vs. 10% as their assumption.

More than half of clinically tested drugs currently undergo phases 2 and 3. This leads to prediction of growth mostly in phase 3. Such trials usually have largest patient enrolment numbers and thus are the biggest.

In 2001, the EU published the EU Clinical Trials Directive, which aims at harmonizing national regulatory frameworks. The key impact of the Directive is that every member state became responsible for creating separate regulations that transpose the Directive into national law. It also saw the establishment of the EudraCT, a database of all interventional clinical trials of investigational medicinal products in the EU. This, however, does not necessarily mean that conducting clinical trials in Europe is easier than before. Despite the attempt to create a unified clinical trial regulatory framework throughout the EU, there remains differences in practice. One company that exports abroad told us that there are still headaches regarding import licenses for Eastern Europe, but these problems are decreasing. For instance, Poland still requires the submission of a signed contract, whereas usually a template is sufficient in other countries. Such local variations inevitably demand more corporate resources.

The above data shows that the pharmaceutical sector and clinical trials have not been hit by the global economic crisis as much as other industries. Ongoing large scale growth is predicted to continue with the shift of focus to the emerging countries. Another trend shaping up lately is the outsourcing of trials currently conducted in-house by pharmaceutical companies themselves to CROs. This is where the demand for experienced work force with relevant training comes into the picture. Mostly these are physicians, pharmacists and other staff with higher education. However, there is a growing interest in high school graduates such as nurses, laboratory assistants, etc.

Russia and Eastern Europe is one of the most attractive regions to conduct clinical trials.

Russia	142.2 million
Ukraine	46.6 million
Poland	38.1 million
Czech Republic	10.5 million
Belarus	10 million
Bulgaria	7.7 million
Lithuania	3.4 million
Latvia	2.3 million
Estonia	1.3 million
Total:	262.1 million

• Centralized healthcare system with the developed referral network and a number of private practices. As a result - few sites needed to get a large number of patients.
• Good selection of high-quality investigational sites.
• ICH-GCP compliance principles incorporated into legislation.
• High recruitment rates with low drop-out rates: Patient recruitment rates in the region is up to 10 times higher than in US and EU.
• Savings in costs: Average cost per patient in Eastern Europe is 28% lower than in Western Europe and 47% than in the UK Possibility to reduce clinical trial expenditure by using local CROs and labs.
• High level of qualification of investigators for conducting clinical trials. As a result the quality of clinical trial data is high.

The Pharmaceutical industry is the highly regulated sector in Europe. Enclosed is the detailed report on Clinical Trials with Medicines in Europe published by European Federation of Pharmaceutical Industries and Associations - http://www.zdrave.net/DOCUMENT/INSTITUTE/e-library/EFPIA//10_Kniga/clinical.pdf