EMA paper addresses first-in-human trial guidelines

In a concept paper released Thursday, EMA outlined proposed topics to consider as part of a planned revision to the agency's 2007 guideline on first-in-human clinical trials. Comments on the paper are due Sept. 30, and EMA expects to publish a new draft guideline by YE16.

In the paper, the agency said many first-in-human studies now use integrated protocols that combine different designs. The existing guideline focuses on single-ascending dose designs, reflecting common practice when it was drafted. ...