Clinical Trials in Russia 2008. Russia Compared to Other Countries

PMR Ltd, April 2008, Pages: 71

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. In this directory of major players you will find an easy reference to such information as contact details (address, telephone and fax number, e-mail address, website) as well as brief description of a company in case of CROs).

Key Facts

- The relatively cheap and productive Russian market is promising, but has its specific risks.

- Moscow and St. Petersburg dominate the clinical trials market.

- In 2007 the most prevalent clinical studies in Russia were phase III trials.

- Russian market is far from saturated.

- The Russian market of clinical trials emerged in the late 1980s.

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.

I. Report methodology

II. Executive summary

III. Background

IV. 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

V. 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

VI. 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

VII. 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

VIII. Attitudes to clinical trials in Russia
General attitudes towards clinical trials
Effectiveness of recruitment tools
Physicians' attitudes
Officials' attitudes

IX. Basic demographic facts
Russia’s population and its density
Prevalence of illnesses in Russia

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

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

Key Sections

Section one provides extensive information on the clinical trials market in Russia. It discusses its size and structure, as well as the number of trials and patients involved. It presents forecasts for 2008- 2012 and analyses current and anticipated market growth opportunities and obstacles. It also includes information on profiles and market situation of companies active on the market in 2006 and 2007.

Section two analyses the results of a survey carried out among such research companies. It evaluates the current market situation, and presents forecasts for the year 2008. Business development opportunities and obstacles are discussed, together with market development expectations of companies for 2008-2009. It also compares Russia’s clinical research environment with that of other countries in Central and Eastern Europe.

Section three provides readers with essential and up-to-date information on the legal aspects of clinical research in Russia.

Section four examines basic attitudes to clinical trials in Russia.

Section five presents some basic facts on demography and healthcare in Russia, with special attention given to Russia’s population, its density and the prevalence of illnesses in the country.

Report Overview

Following a brief summary, background presentation and a description of the methodology employed in the report, Clinical trials in Russia 2008 provides an in-depth overview of the Russian clinical trials market with special emphasis on:
- the market’s size and structure
- the number of trials and patients involved, followed by forecasts for 2008-2012
- current and anticipated market growth opportunities and obstacles.

The report then presents characteristics of the main companies conducting clinical research in Russia in 2006 and 2007, with special focus on:
- companies’ origins and workforce
- the number of patients participating in trials per company
- companies’ main areas of interest, according to therapeutic groups and study phases.

We then discuss a survey carried out on the management staff of companies active on the market. The results include the following:
- an evaluation of the current situation on the clinical research market and forecasts for 2008
- opportunities for and obstacles to business development on the market
- a market development forecast for 2008-2009
- a comparative analysis of the clinical research environment in Russia and in other Central and Eastern European countries
- the average registration time for clinical trials in Russia.

The report also provides a thorough examination of the legal aspects and conditions of clinical research, with special attention given to the following issues:
- major legislation governing clinical research in Russia
- principles and procedures in clinical trials
- side effects and safety monitoring
- insurance for clinical trials
- taxes
- contracts and fees in clinical trials.

Finally, the report outlines the prevailing attitudes to clinical trials in Russia and presents some basic facts on demography and healthcare in the country, with particular emphasis on:
- Russia’s population and its density
- prevalence of illnesses in Russia.

A word from the expert

“The Russian market has recently become attractive for many businesses. One of the sectors eyed with keen interest is clinical research. However, investing in this market is still highly challenging. Our report provides market insight from the perspective of companies engaging in clinical research in Russia, based on a survey conducted among the firms. We believe this to be the best way to show the practical pros and cons of conducting clinical trials in Russia. Our report is a synthesis of our desk research and the industry's expertise.”

Monika Stefanczyk, Senior Pharmaceutical Analyst

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