Posted by Michael Wonder on 25 Jul 2017
Revised guideline on first-in-human clinical trials
25 July 2017 - Guidance outlines strategies to identify and mitigate risks for trial participants.
The EMA has revised its guidance on first-in-human clinical trials to further help stakeholders identify and mitigate risks for trial participants.
The safety and well-being of trial participants should always be the utmost priority when designing early clinical trials. The guideline puts emphasis on the sponsor’s responsibility to define the uncertainty associated with the medicine tested at each step of the development and to describe how the potential risks that might arise from this uncertainty will be addressed within the design and conduct of the trial. The approach must be supported by a well-documented scientific rationale from the outset and be responsive to data emerging over the course of the trial itself.
