Improving safety of first-in-human clinical trials.

The article focuses on the review started by agency for protection of public and animal health through supervision of medicines European Medicines Agency (EMA) of the guidelines that describe first-in-human clinical trials and the data needed to enable their appropriate design and allow initiation. It discusses the review being done in cooperation with the European Commission and Member States of the European Union (EU). It mention the need for improving safety of human volunteers in trials.