Clinical Trials Directive slows registration of paediatric studies.

摘要

Registration of new non-commercial paediatric trials in Europe essential for optimising paediatric treatments-has fallen since the Clinical Trials Directive 2001/20/EC was implemented, according to sarcoma experts meeting in Stuttgart, Germany (Nov 30-Dec 2, 2006). "Before implementation, 10-20 studies were opened per year in the UK, but this has now fallen to just a handful", says Kathy Pritchard-Jones (Royal Marsden Hospital, London, UK). "Treatment within a trial is associated with definite survival advantage and, with fewer trials available, we must fear cure rates in Europe will decline as a direct consequence of legislation which was originally intended to protect patients", Stefan Bielack (Olgahospital, Stuttgart, Germany) told The Lancet Oncology (TLO).