New R&D models and innovative clinical trials methodologies
The role of the new clinical trials legislation

Susanna Del Signore, Associate Vice-President Global Regulatory Affairs, Head of Global Regulatory Policy, Sanofi R&D, France

Researching and developing new medicines demands high levels of innovation. This in turn delivers insights that benefits both society and patients. This research is dependent on clinical trials; without these, there would be no new medicines, no improvement of existing medicines and no evidence-based improvement in how we use current treatments.

Despite this, the number of clinical trials undertaken in Europe is decreasing. Clearly, if we wish to stimulate healthcare R&D, we need a robust, operative and cost-effective EU framework for clinical trials.

This theme will examine how we can use the new legal framework for clinical trials to create this environment. How can we simplify processes whilst safeguarding the rights and safety of the clinical trial subject? What are the considerations for clinical trial design, such as location and disclosure requirements? Practically, how can we have a regulatory system that lets us respond quickly to the demands of an ageing population and a rapid rise in chronic conditions?