GENE THERAPY ADVISORY COMMITTEE
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GENE THERAPY ADVISORY COMMITTEE |
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| Note of the twenty-third meeting of the Gene Therapy Advisory Committee (GTAC) held on 11 & 12 May 1999. DAY 1 - 11 May 1999. Present Professor Norman C Nevin (Chair), Mrs Rosie Barnes, Canon Dr Keith Denison, Mrs Ann Hunt, Professor James Neil, Mrs Irene Train, Professor John Burn, Professor Patrick Johnston, Dr Brenda Gibson. Secretariat Dr Jayne Spink, Mrs Margaret Straughan. Also Present Dr Jenny Sims (Medicines Control Agency) & Dr George Hasse (Medicines Control Agency), Ms Pamela Mortimer (Department of Health). The meeting discussed the following issues: Flagging of gene therapy patients on the NHS Register. The Secretariat are to complete an application to the Office of National Statistics and the relevant research ethics committee for the flagging of gene therapy patients on the NHS central register and circulate this to members. Appointment of New Members. Applications from prospective members were being processed. It is hoped that the successful applicants would be able to take up their duties by the July meeting. Application from the Christie Hospital Manchester, Royal Bournmouth Hospital & Royal South Hampshire Hospital for gene therapy in follicle centre lymphoma. The trial was granted approval subject to receipt of minor amendments to the patient information leaflet. Two proposals for gene therapy from Queen Elizabeth Hospital, Birmingham for gene therapy in liver and head & neck cancer. The Committee agreed that it could not approve either study at this time. It was agreed that the proposers be encouraged to submit a revised protocol taking into account the issues raised by members and to provide further supporting data for consideration. Presentation & Discussion: Potential use of DNA repair as gene therapy. An interesting presentation was given by the investigator, followed by a question and answer session. The Committee agreed that the presentation of such "pre-proposal" at a very early stage in development was extremely helpful. DAY 2 - 12 May 1999. Present Professor Norman C Nevin (Chair), Mrs Rosie Barnes, Canon Dr Keith Denison, Mrs Ann Hunt, Professor James Neil, Mrs Irene Train, Professor John Burn, Dr Brenda Gibson, Professor Elizabeth Anionwu, Professor Ian Hart, Professor Anthony Pinching, Professor Anthony Dayan. Secretariat. Dr Jayne Spink, Mrs Margaret Straughan. Also Present. Dr Jenny Sims (Medicines Control Agency), Mrs Marcia Fry (Department of Health). The meeting discussed the following issues: Resubmission of a gene therapy proposal from St George's Hospital, London for the treatment of malignant melanoma. This submission was originally considered by GTAC on 10 February 1999 (see minutes of the 22nd meeting). The Committee agreed that conditional approval for the proposed work could now be given, subject to receipt of satisfactory amendments to the protocol and patient information sheet. Proposal from The Royal Marsden Hospital, London for a gene therapy trial in patients with ovarian cancer. The trial was granted conditional approval subject to receipt of satisfactory amendments to the protocol and the patient information sheet. Proposal from the Northern General Hospital & Western Royal Infirmary, Sheffield for the treatment of ovarian cancer. The trial was granted conditional approval subject to satisfactory responses to a number of points and to amendments to the protocol and patient information sheet. Discussion of a submission from the Beatson Institute Glasgow for the treatment of head & neck cancer. The final proposal had reached the Secretariat too late to be reviewed in time for and consideration at today's meeting but was circulated to members for comments. The Committee agreed to convene a subgroup to discuss issues arising with the principal investigator. Reports to the Committee GTAC heard reports from the Chairman and Secretariat on the following matters; · The continuing increase in numbers of submissions to GTAC. · The Wellcome Trust's "Medicines in Society" programme. Dates of the Next Meetings. Wednesday, 14 July 1999. Wednesday, 13 October 1999. Wednesday, 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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