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Clinical trials in Russia 2008 Russia compared to other countries

April 2008
Pages: 71
Delivery: PDF


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Based on a comprehensive survey carried out on the management staff from almost fifty companies, Clinical trials in Russia 2008 offers an extensive overview of Russia’s clinical trials market in the context of other Central and Eastern European countries. Its exhaustive analysis of current and prospective market trends and a detailed discussion of the market’s legal aspects, provide an all-embracing picture of the sector.

As a supplement, the report offers a directory of Contract Research Organisations and pharmaceutical companies active in clinical trials in Russia.


This report is essential reading for:
  • the senior management of companies active on the clinical trials market
  • clinical Research Organisations and pharmaceutical companies interested in launching operations in Russia or cooperating with their Russian counterparts
  • companies interested in providing medical products and equipment for the clinical trials market in Russia
  • pharmaceutical companies and CROs keen to keep track of Russia’s rapidly growing clinical trials market
  • decision makers who, for professional reasons, need to gain a thorough understanding of the key trends on the market.

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  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

  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
Clinical trials in Russia 2008
Russia compared to other countries

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