New EU rules set to inject new life into clinical trials

Clinical trials are set to become better, faster and safer under new rules unanimously approved by the European Parliament's public health committee last week. The rules will have to be approved by the EP, during the October plenary as well as by the Council before they can enter into force.

The new text makes specific provision for low-risk trials, clarifies the duties of ethics committees and details how to obtain informed consent from patients. The new law features simplified reporting procedures, and empowers the European Commission to conduct checks. Once a clinical trial sponsor has submitted an application dossier to an EU member state, it will have to respond within fixed deadlines.

Members of the EP (MEPs) amended the draft text to improve transparency, by requiring that detailed summaries be published in a publicly accessible EU database, with full Clinical Study Reports published once a decision on authorization is complete.