GTAC - Note of the 50th meeting
15 September 2004 |
Present: Professor Norman Nevin (Chair), Professor Terry Hamblin,
Professor Jim Neil, Rev Dr Lee Rayfield, Dr Adrian Lepper, Dr Richard
Ashcroft, Professor Andrew Lever, Mr Michael Harrison, Professor David
Harrison, Dr Michael Waterhouse, Mrs Debbie Beirne, Professor Nick Lemoine,
Professor Martin Gore, Dr Caroline Benjamin, Professor Alex Markham.
Secretariat: Dr Monika Preuss, Dr Jayne Spink, Dr Cathleen Schulte,
Mr Daniel Gooch.
Item 1: Welcome
The Chair welcomed the Committee to its fiftieth meeting, held at the
Department of Health, Elephant and Castle, London.
Item 2: Minutes of the 49th meeting of GTAC
The minutes were agreed as an accurate and true record of the meeting.
Item 3: Matters Arising
Correspondence. The several letters sent out concerning correspondence
arising from the last meeting did not lead to any substantial discussion.
Feedback from GTAC Public Day in Cambridge. The Secretariat has
provided an analysis of the 60 feedback forms received from the approximately
90 attendees of the GTAC public day in Cambridge. The day was extremely
well received. Members provided some suggestions for location and content
for the next meeting.
Item 4: Chairman's Actions
Since the last GTAC meeting, eleven Chairman's Actions had been taken
which were discussed briefly.
Item 5: GTAC 094: A Phase II exploratory study of the efficacy and
safety of OncoVEXGM-CSF in combination with Arimidex in the neoadjuvant
treatment of breast cancer in post menopausal women with oestrogen receptor
positive tumours
This protocol uses a Herpes Simplex Virus vector as a potential treatment
of solid tumours, in this case breast cancer. The trial aims to recruit
post-menopausal women with breast cancer where tumours express a surface
protein called oestrogen receptor (ER). The trial aims to compare the
response in patients who receive the product in combination with hormone
treatment with patients who receive hormones only. After considerable
discussion of the proposal with the proposers, GTAC decided to decline
the application, giving feedback on what would need to be done before
submitting a new application based on the original.
Item 6: SAE update
A number of new SAEs had been received since the last meeting covering
5 trials. There were no concerns.
Item 7: Safety reports
The committee discussed briefly how annual safety reports should be
processed in future.
Item 8: GTAC training elective: Presentation by ABI on insurance and
clinical trials
Mr Richard Walsh of the Association of British Insurers (ABI) gave
a short presentation on clinical trials and insurance.
Item 9: Updated guidance for writing PILs
At the GTAC meeting in June, there was a discussion on the merits of updating
GTAC's guidance on writing information leaflets for those participating
in gene therapy research. The Secretariat had updated the guidance notes
in line with the suggestions made at that meeting and by comparing GTAC's
guidance with a template PIL published by COREC. Members provided additional
comments, and were invited to provide any final comments by the end of
September.
Item 10: Any other business
An account of 50 GTAC meetings. To commemorate GTAC's 50th meeting
the Secretariat had put together a short anthology of all meetings and
many of the key events since GTAC first met in 1993.
Lentiviral safety. GTAC was informed of the previous day's discussions
of the GTAC subgroup on lentiviral safety and considered how this issue
should be taken forward.
Next meeting: Wednesday and Thursday, 17 and 18 November.
GTAC Secretariat
November 2004
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