Clinical trials and the new European Union legislation

Abstract

Clinical trials are fundamental for the advancement of knowledge in medical sciences (including oncology) therefore strict legal and ethical conditions should be applied to their planning and conducting. Regulation No 536/2014 of the European Parliament was enforced in June 2014 to increase the number of clinical trials conducted in EU Mem­ber States. This new legislation regulates clinical trials and is mandatory in all EU countries. These new rules not only simplify the application procedure for authorization of a clinical trial and shorten waiting time for the authorization to begin study, but also introduce new definitions, including biomedical trials or clinical trials with a low degree of intervention. Particularly significant changes concern non-commercial research, including academic research projects in medicine and trials initiated by investigators (Investigator Initiated Study) based on universities, scientific societies, scientific research groups or research institutes. According to the provisions of the Regulation, it is necessary to take national legislative measures in order to support such projects. Therefore, oncology societes in our country propose means to enhance non-commercial clinical trials to be conducted in Poland.