August 4, 2017
The European Medicines Agency (EMA) has issued new, stricter rules for studies that test drugs in people for the first time. They aim to better protect participants in such first-in-human studies—often healthy volunteers who receive a financial reward.
The guideline, which was issued on 25 July, will take effect in February 2018. It comes in the wake of a tragedy in a French drug study last year that led to the death of one man and serious neurological damage in four others. But some say the revision isn’t going for enough.
The new guideline emphasizes that drug developers must perform comprehensive preclinical tests of a new compound, including how it binds to its target and whether it has so-called off-target effects; experts argue such studies fell short for the French study. EMA also provides more detailed guidance on dosing and how to monitor subjects’ safety. Trial sponsors need to have strategies to minimize risks at every step and have to deal with adverse events timely and adequately.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.