Clinical trials can have unforeseen consequences even where protocol and best practice are followed. This article by Katie Chandler of Taylor Wessing looks at the risks, liability and insurance issues relating to clinical trials. She examines the liability framework, including the clinical trials directive by which clinical trials in the EU are currently governed. Chandler concludes with a consideration of the new Clinical Trial Regulation, which the EU Is currently in the process of preparing for implementing in 2020, within the Brexit transition period.