EMA has launched a public consultation on the draft ICH Guideline E19 relating to optimization of safety data collection in late-stage pre-approval or post approval studies and promoting selective safety data collection to limit useless burden to study participants (when the safety profile of a drug is sufficiently characterized).
This guideline explores under what circumstances a targeted approach to safety data collection in some late-stage pre-marketing or post-marketing studies would be appropriate and how to implement such an approach. This approach could reduce the burden to patients which can serve as a disincentive to participation in clinical research, while recognising that protection of patient welfare during medicine development is of critical importance. The aim is to enable a larger number of informative clinical studies to be carried out with greater efficiency and greater global participation in studies, for the benefit of public health.
The draft guideline is available by clicking here.
Comments should be provided using the ad hoc template to be sent to email@example.com by 29 September 2019.