To study the efficacy, safety and quality of new medicines, pharmaceutical companies have to carry out clinical trials before products are allowed onto the market. In these trials, studies are first carried out in healthy volunteers (Phase I), then in a small number of patients (Phase II) and finally in a larger number of patients (Phase III). Only after this can an application for marketing authorization be submitted to the medicines regulatory authority Swissmedic. Once market approval has been granted, the new medicine must be monitored in practice (Phase IV).
Every clinical trial has to be approved by the responsible ethics committee and definitively released by Swissmedic. The number of studies carried out is an indicator of the attractiveness of a research centre. In the last ten years, there has been a marked decrease in clinical research in Switzerland. Since 2007 the number of clinical trials has declined substantially. This trend can be seen in all clinical trial phases.
The master plan approved by the Federal Council in December 2013 with a view to strengthening biomedical research and technology provides for measures to counter this downward trend. Amongst other things, the quality of training for doctors in clinical research at universities and hospitals is to be improved. The Human Research Act, which came into force at the beginning of 2014, aims at speeding up the approval procedure for clinical trials in the ethics committees.