Long-term follow-up of cancer patients treated with gene therapy medicinal products.
European Union requirements are discussed for the long-term follow-up of advanced therapy medicinal products, as well as how they can be applied to cancer patients treated with gene therapy medicinal products in the context of clinical trials, as described in a specific guideline issued by Gene Therapy Working Party at the European Medicine Agency.
Department of Cell Biology and Neurosciences, Istituto Superiore di Sanità, Roma, Italy. mariacristina.galli@iss. it
Maria Cristina
MC
Galli
D003695:Delivery of Health Care; D005062:European Union; D005500:Follow-Up Studies; D015316:Genetic Therapy / Q000592:standards*; D006801:Humans; D009369:Neoplasms / Q000235:genetics / Q000628:therapy*