BioCentury
ARTICLE | Politics & Policy

EMA to review first-in-human guidelines

May 28, 2016 1:05 AM UTC

EMA said it has begun a review of its guidelines for first-in-human clinical trials following a patient death and several hospitalizations that occurred in January during a French Phase I study (see BioCentury Extra, Jan. 15).

One agency group is evaluating preclinical data that are required to begin human testing, while another will study the design of first-in-human trials. The agency plans to produce a concept paper by July that will identify areas for change to minimize risk in future studies. It intends to hold a public consultation on the paper this year. ...