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MINUTES OF THE 27TH MEETING OF GTAC HELD ON 10 MAY 2000 IN ROOM 102
SKIPTON HOUSE, ELEPHANT AND CASTLE, LONDON SE1
Present:
Professor Norman C Nevin (Chair),
Professor James Neil,
Canon Dr Keith Denison,
Mrs Ann Hunt,
Mrs Irene Train,
Mrs Rosie Barnes,
Professor Anthony Pinching,
Professor C Michael Steel,
Professor Ian Hart,
Dr Brian Davis (MCA),
Dr Lincoln Tsang (MCA)
Secretariat:
Dr Jayne Spink,
Dr Mark Bale,
Mrs Margaret Straughan,
Mrs Beryl Keeley
1. Welcome and Apologies.
The Chairman welcomed the Members and informed them that there would be
three protocols for this meeting. Apologies had been received from Professors
Elizabeth Anionwu, Paddy Johnston, Tony Dayan, John Burn, Dr Elaine Gadd,
Mrs Fry and Mr Michael Harrison.
2. Minutes of 26th Meeting.
These had been circulated and apart from one minor amendment were accepted
as a true record.
3. Matters arising.
Adenovirus Working Party.
The working party met on 11 April 2000 with the following remit:
- To review current UK practice in adenoviral gene therapy clinical
trials, including adverse event reporting;
- To establish recommendations in relation to GTAC's guidance with
respect to adenoviral gene therapy clinical trials.
A draft report had been circulated to the working group members and a final
report will be issued as a supplement to GTAC's Guidance Notes.
NETS subgroup - progress ad timing of new guidance.
The subgroup had met on 7 April to discuss the revised GTAC guidance notes
at which the subgroup agreed the definition of gene therapy. An outline
of the guidance and timetable for completion was discussed. The members
of the subgroup endorsed the application form.
Update on the European Clinical Trials Directive.
Dr Davis informed the Committee that consensus had been reached and if
there were no major amendments the text would be available by the end
of 2000.
4. Protocol: Donor vaccination following allogenic bone marrow transplantation
for multiple myeloma.
The Chairman summarised the background to the Members. The investigators
had submitted three separate protocols:
(i) Extending their previously approved protocol for follicular lymphoma
to CLL
(ii) Extending their previously approved protocol for follicular lymphoma
to CLL to multiple myeloma
(iii) Vaccination lymphocte donors (for multiple myeloma).
The first two extensions were granted approval by Chairman's action in
April following favourable review by external assessor. After discussion
it was agreed to give conditional approval to the donor vaccination project
subject to amendments to the patient and donor information sheets and
consent forms.
5. Protocol: A phase III multicentre trail to test the concept of durable
virological suppression in subjects with HIV-1 infection or recent seroconversion.
It was agreed that minor amendments would be required to the patient information
leaflet.
6. Protocol: A phase I dose escalation trial to assess the safety and
immunogenicity of DISC-GMSCF in patients with metastatic melanoma.
The Chairman informed the Members that the proposal had been favourably
reviewed by the external assessors. After discussion it was agreed to
give approval to this study.
7. Chairman's Actions.
A complete list of amendments approved by Chairman's action over the first
4 months of year 2000 was tabled for information. A total of 12 approvals
are listed and some of these cover up to 15 minor amendments on which
some of the Members had been asked to give assessments on. The rate of
submissions for amendments is three per month.
8. Any Other Business.
SAE reports
Two notifications had been received.
· A patient participating in a gene therapy trial in the US had
died of progressive disease.
· An SAE in a UK study which was deemed not to be in any way related
to the study drug.
GTAC Application Form.
Members were asked to review a new protocol, using information submitted
on the pilot GTAC application form, and let the Secretariat have responses
on whether this should be dealt with in full committee, Chairman's action,
Secretarial review or external assessors, and the reasons for their decision.
Also suggestions were invited in relation to the design of the form.
Retirement of Members
The terms of office of half of the committee will end at the end of
June 2000. Elizabeth Anionwu, John Burn and Brenda Gibson will retire.
The Chairman and Secretariat thanked all these members for their contributions
to the Committee. It is hoped to have replacements for these retiring
members by the July meeting.
9. Dates of remaining meetings for 2000
Wednesday, 19 July
Wednesday, 11 October
Tuesday, 12 December
GTAC Secretariat
May 20/00
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