Conducting Clinical Trials in Europe: An Insider's Analysis

리서치사	Insight Pharma Reports
발행일	2008년 12월	상품코드	82158
페이지 정보	250 pages
가격	US $ 2,995 ￦ 3,568,500 PDF by E-mail ( Single User License) US $ 3,750 ￦ 4,468,100 PDF by E-mail (Single Site License)

한글목차
영문목차
관련자료

영문목차

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.

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