Abstract
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
Conducting Clinical Trials in Europe: 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.
Table of Contents
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
Figures
- Figure 4.1. Process of Clinical Trial Approval in Russia
- Figure 4.2. Structure of the Regulatory Authorities and Ethics Committees
in Ukraine
- Figure 4.3. Process for Approval of Clinical Trials in Belarus
- Figure 4.4. Process for Approval of Clinical Trials in Georgia
- Figure 5.1. Outcomes of FDA Inspections since 1994 by Region
- Figure 5.2. Detailed Findings of FDA Inspections since 1994 by Region
Tables
- Table 5.1. Clinical Trial Submission Timelines - United States
- Table 5.2. Clinical Trial Submission Timelines - EMEA Member States
- Table 5.3. Clinical Trial Submission Timelines - Non-EMEA Countries
- Table 5.4. Clinical Trial Submission Timelines - Russia and CIS
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