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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

Contents

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

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