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Clinical trials in practice: what do you need to know?

VETERINARY surgeons undertaking clinical research, either independently or as part of a wider research programme, need to be aware of the legal controls on such studies. As James Anderson and Helen Jukes explain, many studies can be carried out under the Veterinary Surgeons Act, provided that all clinical investigations and treatments are for the benefit of the animal and that authorised medicines are used. However, for studies that involve, for example, further sampling or use of unauthorised products, additional authorities will be required. Although securing appropriate authorisation from the Veterinary Medicines Directorate (VMD) and/or under the Animals (Scientific Procedures) Act may seem daunting, helpful advice is available from veterinary advisers at the VMD and from Home Office inspectors, and many duly authorised clinical trials are undertaken each year.

James Anderson graduated from Glasgow in 1966. After completing a PhD in cellular immunology, he worked at the Institute for Animal Health, Compton. In 1986, he joined the Animals (Scientific Procedures) Inspectorate and retired as a superintending inspector in 2003. He is a fellow of the Royal College of Pathologists.

Helen Jukes graduated from Edinburgh in 1987, and was in small animal practice before joining the Veterinary Medicines Directorate in 2003. She is responsible for the assessment of efficacy and target species safety data for applications for marketing authorisations for veterinary medicinal products, and for animal test certificates.

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