Gene therapy is a novel approach to treating disease. It is hoped that it will eventually lead to effective and safe medical treatments. However, because long term effects of gene therapy treatments are unknown, GTAC initiated a long term monitoring study of patients involved in gene therapy. This was the first study of its kind anywhere in the world.

The flagging project is now closed to recruitment.

In February 2007, GTAC reviewed the pilot flagging project after 6 years of data had been accumulated. Following this review, GTAC decided that the project should be wound up and that there should be no further recruitment. For further details:

• Download report of GTAC discussion on the review in Portable Document Format
  

Historical information

The NHS records of patients who participate in these trials were given a code or "flagged." This allowed GTAC to monitor the health of both particpants and their children up to the age of 16 years. Inquiries weremade about patients' health via their GPs and no personal details were disclosed, only the patients' NHS number. Consent from each patient's participation in the project was required. In addition, South Thames Multi-Centre Ethics Commmittee considered and approved the GTAC study. The records were co-ordinated by the Office of National Statistics. The project roll-out began in early 2001. More details on the project are available in the reference below:
Nevin N. & Spink, J. "Gene Therapy Advisory Committee Long Term Monitoring of Patients Participating in Gene Therapy." Human Gene Therapy (2000) 11:1253-1255

In September 2005, a meeting took place of a GTAC working group on the long term monitoring of gene therapy volunteers. The meeting had the following aims:

• to review the current practice on the flagging of patients enrolled in gene therapy studies.
• to explore the clinical, scientific and ethical issues of long-term monitoring.
• to obtain input from interested parties on the flagging project.
• to make recommendations in relation to the future design and execution of the flagging project.

The group issued a report which contained a number of recommendations. This report, in particular Recommendation 4, was considered by GTAC at its September meeting. GTAC decided to grant exemption from the flagging project to trials that use low risk products, for instance those that have a very low risk of affecting vector integration and recombination (for instance: antisense oligonucleotides, plasmid DNA and vaccinia derived vectors). Volunteers in trials that use integrating vectors such as retroviruses and lentiviruses should be offered participation in the flagging project, as should be those receiving AVV and HSV derived vectors unless a convincing rationale to the contrary is given. In case of doubt, researchers are encouraged to contact the GTAC secretariat.

• Download report of the September 2005 workshop in Portable Document Format
• Download Patient information and consent form in Word 97 format
• Flagging form in Word 97 format
  

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copyright: © | last updated 14 May 2007