In January 2017, following the adoption of integrated addendum update to GCP, ICH announced their longer term plans for more extensive revision to ICH-GCP in a reflection paper, “GCP Renovation”:
MoreTrials response to the reflection paper – which you can download below – welcomed the proposals from ICH for a more extensive revision of ICH-GCP, but recommended that the starting point for this should be setting out those few key principles that really matter when doing a randomised trial. Our letter also pointed out that the proposals did not go far enough to address concerns about openness and transparency and the need to involve all stakeholders in the development of a new GCP.
08 March 2017 Response to ICH Renovation Plan from MoreTrials Collaboration
ICH have not responded to our letter.
