Figure 1. Schematic Presentation of Differences in the Scope of National Laws Governing Clinical Trials in Europe.

Legislative acts in each member state were recently revised to cope with the requirements of the CTD 2001/20/EC. Shadowed boxes indicate revised legislation in response to the Directive. The German ordinance on irradiation protection (Strahlenschutzverordnung) and the Italian decree on clinical research for the improvement of clinical practice (Decreto 17 Dec 04) constitute two accompanying legal acts. The term multi-modal therapy trials refers to trials that evaluate the effects of drug therapy together with other forms of medical intervention, e.g., irradiation, surgery, other procedures.