Development of procedures to address health and safety issues in the administration of gene therapy within the clinical setting

Background. The Cancer Research UK Medical Oncology Unit is a clinical research unit with a 16- bed inpatient facility. Clinical research pharmacists are integral members of the multidisciplinary team. In the last three years, six gene therapy clinical trials have been undertaken, requiring containment level one facilities. The vectors used for gene transfer in these studies included inactivated retrovirus, adenovirus, herpes simplex virus and vaccinia.

Purpose. The aim of this paper is to highlight the procedures used throughout the clinical trial process, including storage, handling and disposal of the vectors, to minimize the health and safety risk to staff, patients and the environment.

Findings. Little researched evidence is available on the clinical implications of gene therapy, especially with regard to health and safety. Published literature and protocol guidelines were reviewed. Visits were made to other sites administering gene therapy, and national and international symposia were attended. Standard operating procedures for handling containment level one gene therapy vectors were produced to ensure safe practice. These are in accordance with current UK Health and Safety Executive guidelines.

Conclusions. The future treatment of the patient with cancer will conceivably involve genetic modification. There is, therefore, an urgent need for further research into the safety of these therapies to patients, clinicians, the general public and the environment. This is a new and exciting area for practice research.