A vast new opportunity for clinical trials has emerged in Europe as a result of the collapse of the Soviet Union and events during the last decade of the 20th century. The result is the emergence of dozens of sovereign countries and gone is the political dividing line between East and West Europe. Now these countries join the countries of Western Europe as well as the CIS to offer a spectrum of clinical trial options. Among these are:

Treatment-naive populations
Ease of patient recruiting
Superb trial administration
Lower costs
Applicable EMEA standards or equivalents

European Clinical Trial Site Options: An Insider' s Analysis, authored by a CRO executive living in Serbia, provides a penetrating review and summation on the state of and opportunities for clinical trial programs in 44 countries organized into three categories.

EU Member States and applicants Non EU affiliated states Membership of the CIS

A standardized template is employed to summarize the salient aspects for each country. The information includes:

Geographic and population information
Recent political history and religious demographics
Type of healthcare system, its funding and distribution
Regulatory structure governing clinical trials
Policies, procedures, timelines and fee structures for single and multi-site clinical trial applications
Past clinical trial history and FDA inspection data if available
Quality of medical staff training, English proficiency, and clinical interest
Plus - "insider" comments on the pros and cons to expect

The clinical trials industry in the developed countries in Europe is a mature and expensive option. Most of these populations are treatment savvy and due to competition patient recruiting can be difficult and time consuming. These considerations have driven companies to consider India and China as sites for clinical trials. However, differences in medical practices and training as well as problems with English language fluency can become extremely problematic. The current definition of Europe, all territory west of the Urals, has opened the opportunities for clinical trials.

CHAPTER 1: INTRODUCTION: THE CLINICAL TRIALS MARKET - A VIEW FROM EUROPE

1.1. Europe - A Definition
1.2. Clinical Trials in Europe
1.3. The History of Clinical Trials and their Regulation
- The Origin of Clinical Trials
  - Clinical Trials in the 19th and 20th Centuries
- Clinical Trials Today and ICH-GCP
1.4. The EMEA
- History
- Marketing Application and Approval Process
- Organizational Structure
- Other Services
- The Future of the EMEA
1.5. The EU Directive
- Content of European Clinical Trials Directive
- Effects of Implementation of EU Clinical Trial Directive

CHAPTER 2: EMEA MEMBER STATES

2.1. Basic Structure of a Clinical Trial Submission within all EMEA Member States
- EudraCT
- Ethics Committees and Competent Authorities
- Clinical Trial Amendments
- Declaration of the End of a Clinical Trial
- Import License and the Role of QP
- Further Information
2.2. Austria
- Country Description
- Clinical Trials in Austria - A Brief Overview and History
- Process for Conducting a Clinical Trial in Austria
- Ethics Committees
- Competent Authority
- Import Licenses
- Costs
- FDA Inspection Results
- Insider Tips
2.3. Belgium
2.4. Bulgaria
2.5. Cyprus
2.6. Czech Republic
2.7. Denmark
2.8. Estonia
2.9. Finland
2.10. France
2.11. Germany
2.12. Greece
2.13. Hungary
2.14. Iceland
2.15. Ireland
2.16. Italy
2.17. Latvia
2.18. Liechtenstein
2.19. Lithuania
2.20. Luxembourg
2.21. Malta
2.22. The Netherlands
2.23. Norway
2.24. Poland
2.25. Portugal
2.26. Romania
2.27. Slovakia
2.28. Slovenia
2.29. Spain
2.30. Sweden
2.31. United Kingdom

CHAPTER 3: NON-EMEA COUNTRIES IN EUROPEAN AREA

3.1. Albania
3.2. Bosnia
3.3. Croatia
3.4. Macedonia
3.5. Montenegro
3.6. Serbia
3.7. Switzerland
3.8. Turkey

CHAPTER 4: RUSSIA AND CIS EUROPEAN COUNTRIES

4.1. Russia
4.2. Ukraine
4.3. Belarus
4.4. Georgia
4.5. Moldova
4.6. Armenia
4.7. Non European CIS countries: Azerbaijan, Kazakhstan, Kyrgyzstan, Tajikistan and Uzbekistan
- Azerbaijan (Joined CIS in 1991)
- Kazakhstan (Joined CIS in 1991)
- Kyrgyzstan (Joined CIS in 1991)
- Tajikistan (Joined CIS in 1991)
- Uzbekistan (Joined CIS in 1991)

CHAPTER 5: COMPARISON TO THE UNITED STATES

5.1. FDA Inspections in Europe
- FDA Inspection Outcomes
  - Comparison with EMEA Member States
  - Comparison with Non-EMEA European Countries
  - Comparison with Russia and the CIS
- FDA Inspection Detailed Findings: Site Deficiencies
  - Comparison with EMEA Member States
  - Comparison with Non-EMEA European Countries
  - Comparison with Russia and the CIS
5.2. Clinical Trial Submission Timelines
United States
EMEA Member States
Non-EMEA Countries
Russia and CIS

CHAPTER 6: WHAT THE FUTURE HOLDS FOR EUROPEAN TRIALS, EMERGING MARKETS IN EUROPE

6.1. EMEA Countries' Future
- EU CT Directive
- Electronic Submissions
- Information Exchange
6.2. Non-EMEA Countries' Future
- EU CT Directive and Timelines
- Recruitment Figures
- Costs
- Quality
6.3. Russia and CIS Future
- EU CT Directive and Timelines
- Costs and Quality

CHAPTER 7: APPENDICES

Appendix A: Glossary of Selected Abbreviations
Appendix B: Glossary of Selected Terms
Appendix C: Relevant Contact Details and Addresses including Web Links
REFERENCES
COMPANY INDEX WITH WEB ADDRESSES

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European Clinical Trial Site Options: An Insider's Analysis Overview