Website of the Department of Health

Please note that this website has a UK government access keys system.

Main menu

Page menu

Publications

Expert Group on Phase One Clinical Trials: Final report

Document type:

Report
Author:

Expert Group on Phase One Clinical Trials (Chairman: Professor Gordon W. Duff)
Published date:

7 December 2006
Primary audience:

Health and social care professionals
Product number:

10011703722 2
Gateway reference:

Not required
Copyright holder:

Crown

Final report of the Expert Scientific Group (ESG) which was set up following the very serious adverse reactions that occurred in the first-in-man clinical trial of TGN412 in March 2006. The trial was performed in a private clinical research unit at Northwick Park. This report was an independent report to the Secretary of State for Health.

Published by TSO (The Stationery Office) priced £125.00

1. Executive Summary

2. Introduction

3. Background to the TGN1412 incident as at July 2006
Prepared by the Secretariat to the ESG
A Pre-clinical development of TGN1412
B Transition to Clinical Development of TGN1412
C Phase One Clinical Trial and Adverse Events at Northwick Park Hospital
D MHRA GCP, GMP and GLP Investigations

4. Paper published in the New England Journal of Medicine

5. NIBSC Special Cytokine Study and Follow Up Studies

6. Summary of Stakeholder Consultations

7. Predicting Hazards in Pre-clinical to Clinical Transition

8. Risk Reduction and Risk Management

9. Scope and Summary of the Recommendations

10. Appendices

Appendix A. Meetings, Papers and Minutes of the ESG
Appendix B. List of invited stakeholders & stakeholder consultations
Appendix C. Stakeholder Meetings Minutes and Presentations
Appendix D. Stakeholder Written Submissions D
Appendix E. Comments on Interim Report
Appendix F. List of Invited Observers
Appendix G. Observers Submissions
Appendix H. History of Phase One Clinical Trials in the UK
Appendix I. Membership of the Expert Scientific Group
Appendix J. Secretariat and Professional Supporting Staff
Appendix K. Table of Results for Laboratory Analysis
Appendix L. Glossary

Additional links

Ordering publications

Contact details for obtaining hard-copy DH publications.

Ordering publications

Help viewing PDFs

Help viewing PDFs

Useful tips to ensure you get the most from PDFs and the free Reader program. Topics covered include accessibility, troubleshooting and searching files.