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Note of the 24th Meeting of the Gene Therapy Advisory Committee (GTAC) held on 14 July 1999.
Present:
Professor Norman C Nevin (Chair), Professor John Burn, Canon Dr Keith Denison, Professor Anthony Pinching, Professor
James Neil, Professor Michael Steel, Professor Elizabeth Anionwu, Professor Anthony Dayan, Mrs Irene Train, Mrs
Rosie Barnes, Mrs Anne Hunt
Secretariat:
Mr Anthony Taylor, Dr Jayne Spink, Mrs Margaret Straughan
Also present:
Dr Elaine Gadd (Department of Health), Ms Kerry Knight (DH), Dr Lincoln Tsang (Medicines Control Agency), Dr Jenny
Sims (MCA)
The meeting discussed the following issues:
Proposal from the Beatson Institute, Glasgow for gene therapy in the treatment of patients with head and neck cancer.
Following reassurances provided to a subgroup that had met with the principal investigator, this proposal was granted
conditional approval, subject to receipt of satisfactory amendments to the protocol and patient information sheet.
Flagging of Gene Therapy Patients on the NHS Central Register.
The draft application to the research ethics committee was discussed and it was agreed that members would respond
to the Secretariat in writing.
Amendment to two proposals from Queen Elizabeth Hospital, Birmingham for gene therapy in head and neck and liver
cancer.
This had been discussed at the last meeting and the Committee had not been able to give approval because of a number
of concerns. These issues had now been addressed and the study was approved.
Application from the Beatson Oncology Centre, Glasgow to extend GTAC approval. A study of gene therapy in primary
malignant gliomas.
In December 1996 GTAC granted approval for the initial stage of a Phase I study. Following completion of this
initial study, confirmation of approval was sought to proceed to the second stage. The Committee agreed to grant
conditional approval subject to the provision of minor additional data items.
Reports to the Committee.
GTAC heard reports from the Chairman and Secretariat on the following matters:
- Government Biotechnology Review.
- A proposal for the NETS subgroup to look at the definition of gene therapy.
- An enquiry at Hammersmith Hospital.
- Appointment of new members.
Dates of next meetings.
These will be held on 13 October and 15 December 1999.
IMPORTANT NOTE.
GTAC considers that gene therapy has not yet developed to the stage where it can be considered as treatment. 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.
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