GTAC - NOTE OF THE THIRTY- FIRST MEETING - 14 FEBRUARY 2001

Go back to referring page

Main Page

NOTE OF THE 31ST MEETING OF GTAC HELD ON 14 FEBRUARY 2001. Present: Professor Norman C Nevin (Chair), Mrs Rosie Barnes, Ms Caroline Benjamin, Mr David Crosby, Professor David Harrison, Mr Michael Harrison, Professor Alex Markham, Professor James Neil, Professor Anthony Pinching, Reverend Dr Lee Rayfield, Mrs Irene Train Observers: Dr Elaine Gadd (DH), Dr Brian Davis (MCA) Secretariat: Dr Jayne Spink, Dr John Connolly, Mrs Margaret Straughan   1. Welcome and Apologies. The Chairman welcomed Members to the first meeting of 2001. Members were informed that up to 1999 each year the Committee considered single figure protocols. In 1999 GTAC considered 7 protocols and in 2000 a total of 21 protocols were considered, which was a three-fold increase in the workload. The Chairman thanked the Members and Secretariat for all their hard work. Minutes of the last meeting. These were circulated to members. Once errors were corrected, these were accepted as a true record. Matters Arising. The committee was informed that the two studies from previous GTAC meetings had been granted conditional approval by chairman's actions since the previous meeting and that, in the case of another protocol, the secretariat would meet with proposers for discussions. Protocol: A Phase I/II study of Immunotherapy for Patients with metastatic melanoma using dendritic cells transfected with a plasmid encoding two melanoma antigens. The chairman informed the committee of the background the protocol. The procedure involves the use of a DNA vaccine approach to boost patients' immune system against melanoma. The proposers made a presentation to the committee. After discussion, it was agreed to grant conditional approval subject to some modifications in the patient information leaflet and protocol content. Discussion of Draft Protocols for trials involving DNA vaccines. Members agreed that this type of proposal falls under the remit of GTAC. It was concluded that there was no material difference between prophylactic and therapeutic vaccines. Nor was there considered to be a significant difference between vaccines in certain cancer trials, which had already been assessed by GTAC, and infectious disease trials. MCA Update on the new Clinical Trials Directive. A representative from the MCA informed members on the progress of the new Clinical trials directive in the European Parliament and how it would be likely to effect GTACs conduct of business. GTAC workshop at Colindale. The members were reminded of the GTAC workshop on Gene therapy for Inherited Disorders, which would take place at Colindale on 2 March 2001. Any Other Business. Members were informed of new regulations by the FDA in the involving xenotransplantation and gene therapy, in which more detail on clinical trials would be made publically available. There was a discussion of conflict of interests, not just financial, amongst investigators during clinical trials and agreed that a new question on this issue would be inserted in GTAC application forms. It was reported that procedures to standardise adenoviral reference material for clinical trials are to be implemented in the US. The GTAC Adenovirus Working Party had previously made this suggestion. Finally, the committee was informed that four new members, two specialists and two lay, would be joining GTAC in the near future.   IMPORTANT NOTE. All gene therapy is research and recruitment of patients into research trials takes place under strict rules set out by GTAC, under principles elaborated by professional bodies and only after review of clinical protocols by GTAC.

Published by the Department of Health
© Crown Copyright 2001
This page last updated 27 March 2001