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- Title
Standards for gene therapy clinical trials based on pro-active risk assessment in a London NHS Teaching Hospital Trust.
- Authors
K.B. Bamford; S. Wood; R.J. Shaw
- Abstract
Conducting gene therapy clinical trials with genetically modified organisms as the vectors presents unique safety and infection control issues. The area is governed by a range of legislation and guidelines, some unique to this field, as well as those pertinent to any area of clinical work. The relevant regulations covering gene therapy using genetically modified vectors are reviewed and illustrated with the approach taken by a large teaching hospital NHS Trust. Key elements were Trust-wide communication and involvement of staff in a pro-active approach to risk management, with specific emphasis on staff training and engagement, waste management, audit and record keeping. This process has led to the development of proposed standards for clinical trials involving genetically modified micro-organisms.
- Subjects
THERAPEUTICS; MEDICAL literature; GENE therapy; CLINICAL medicine
- Publication
QJM: An International Journal of Medicine, 2005, Vol 98, Issue 2, p75
- ISSN
1460-2725
- Publication type
Article
- DOI
10.1093/qjmed/hci013