Table of contents:

1. Report methodology

2. Executive summary

3. Background

4. Overview of the Russian clinical trials market

• Size of the clinical trials market in Russia in 1997-2007
• Structure of the clinical trials market
• Number of trials and patients participating in trials, with forecasts for 2008-2012
• Patient recruitment
• Infrastructure of clinical trials
• Major events and trends on the clinical research market in Russia
• Current events and trends
• Anticipated trends

5. Largest companies conducting clinical research in Russia in 2006 and 2007

• Largest international sponsors in Russia
• Largest national sponsors in Russia
• Workforce size and characteristics
• Number of patients participating in trials
• Main areas of interest of companies conducting clinical trials in Russia
• Phases of clinical trials conducted in 2007
• Foreign operations of local firms

6. Results of survey among companies conducting clinical research in Russia

• Introduction
• Evaluation of situation in Russian clinical research market
• Assessment of current market situation
• Forecasts of market situation in 2008
• Opportunities and barriers to business development in the clinical trials market in Russia
• Key barriers to business development
• Pros and cons of regionalisation of clinical trials in Moscow and other regions
• Key factors conducive to development of operations
• Market development expectations in the years 2008-2009
• Time required to register clinical trials in Russia
• Assessment of financial situation
• Foreign operations
• Comparative analysis of the clinical research environment in Russia and selected other countries

7. Legal aspects of clinical research

• Most important institutions on clinical research market in Russia
• Major legislation regulating clinical trials in Russia
• Approval for conducting clinical trials in Russia
• Principles of Good Clinical Practice
• Procedures connected with the work of ethics committees
• Occurrence of side effects and adverse events during clinical trials
• Inspection of clinical trials
• National inspections
• FDA inspections
• Imports of medicinal products for use in clinical trials
• Insuring clinical trials
• Tax on clinical trials
• Contracts in clinical trials
• Fees in clinical trials
• Laboratory and diagnostic services

8. Attitudes to clinical trials in Russia

• General attitudes towards clinical trials
• Effectiveness of recruitment tools
• Physicians' attitudes
• Officials' attitudes

9. Basic demographic facts

• Russia’s population and its density
• Prevalence of illnesses in Russia

List of graphs and Tables:

List of graphs

1. Number of international clinical trials in Russia, 1992-2007
2. Relative increase of the number of clinical trial in Russia, 1992-2007
3. Structure of trials in Russia, 2004-2007
4. Proportion of randomised and blind trials in trials sponsored by local and international companies in Russia, Q3 2007
5. Russian research centres most involved in clinical trials (number of sites), 2007
6. Number of clinical trials in Russia, 1997-2012
7. Patient recruitment effectiveness in selected CEE countries (number of patients per site), 2007
8. Number of clinical trials approved by RZN in Russia, Q1 2006-Q4 2007
9. Numbers of all, international, and local clinical trials approved in Russia, Q1 2006-Q4 2007
10. The largest international sponsors of trials (by number of trials approved) in Russia, 2006 and 2007
11. The largest international sponsors of trials (by number of trials approved) in Russia, 2000-April 2007
12. Distribution of sponsors’ countries of origin on the Russian clinical trials market, Q4 2007
13. The largest local sponsors of trials (by number of trials approved) in Russia, 2007
14. The largest local sponsors of trials (by number of trials approved) in Russia, 2006
15. The largest international sponsors of trials (by number of patients involved in new trials) in Russia, 2007
16. The largest local sponsors of trials (by number of patients involved in new trials) in Russia, 2007
17. Main areas of interest of companies conducting clinical trials in Russia, by therapeutic area, 2004-2007
18. Main areas of interest of companies conducting clinical trials in Russia, by phase of study, 2004-2007
19. Assessment of current situation on clinical research market in Russia (no. of companies), December 2007
20. Reasons for positive assessment of market situation in Russia (no. of companies), December 2007
21. Will the situation in the clinical research sector in Russia deteriorate, improve or remain unchanged in 2008? (no. of companies), December 2007
22. Why do you think the market situation will improve in 2008 in Russia? (no. of companies), December 2007
23. Key barriers to business development on Russian clinical trials market (no. of companies), December 2007
24. Comparison of distribution of costs in Moscow and regional sites in Russia, 2007
25. Number of clinical sites in different regions in Russia, 2003-2006
26. Main factors which could help your company grow in the coming years in Russia (no. of companies), December 2007
27. Forecasts for the development of the Russian clinical research market in the years 2008-2009 (% of respondents), December 2007
28. Time from protocol approval to FPFV* in selected countries (months), 2007
29. Assessment of the current financial state of your clinical research firm in comparison to 2006 Russia (no. of companies), December 2007
30. Forecast of your company’s financial situation in 2008 in Russia (no. of companies), December 2007
31. Does your firm conduct clinical trials abroad? (% of respondents), December 2007
32. Countries where companies present in Russia also conduct clinical trials (no. of companies), December 2007
33. Delays in issue of permission for clinical trials in selected CEE countries and Russia, 2007
34. Percentage of FDA inspections by region resulting in official action indicated (OAI)
35. FDA inspections in selected CEE countries, 1977-2006
36. Population of Russia (millions), 2001-2010
37. Coefficient of mortality in Russia, 1950-2006
38. Population by age and gender in Russia (’000), 2007
39. Smoking prevalence (% of population) among adult males worldwide

List of tables

1. Pros and cons of conducting clinical research in Moscow and other regions in Russia, 2007
2. Comparative analysis of the conditions for conducting clinical trials in selected countries and in Russia, December 2007

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Clinical Trials in Russia:a market worth noticing in the coming years - May 2008 Some 38,000 patients participated in clinical trials in Russia in 2007. PMR expects continuing high interest among pharmaceutical companies and Contract Research Organisations (CROs) in conducting clinical trials in this area in the years 2008-2009. To receive a full version of this FREE article, please fill in the form below. The article (in a PDF file ) will be sent to your e-mail address. None of this information will be disclosed to third parties. To be assured that we take your privacy seriously, please read our privacy policy. Please fill out all the fields correctly. Information will only be provided if forms are adequately completed.

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