What is a clinical trial?
A medicine that is available to patients is the result of a long and complex process (14 years on average), whether it is developed in an academic research centre or in a pharmaceutical company. At the end of this process, approximately one medicine in ten tested receives a marketing authorization.
The development of a medicine involves several steps. In each one of them, specific questions are asked and specific aspects are assessed. Before a medicine is marketed, it is analysed through non-clinical or preclinical research to determine its mechanism of action and its toxicity. It is then tested on animals as well. If the balance between the benefits and the risks of the medicinal product turns out positive, after all these non-clinical studies have been conducted, clinical trials can be carried out on human volunteers.
Different legislation and submission procedures
- European Regulation 536/2014
- Pilot project European Regulation 536/2014
- Directive 2001/20/EC and Development Safety Update Reports