ICH have just released a press release of their recent meeting in Osaka. What it is says is that they have adopted the proposed update to ICH-GCP. The context is this is the first update to ICH-GCP since it was created 20 years ago.
This is welcome news.
What is also significant is that ICH have also announced plans to review the wider package of guidelines that relate to ICH-GCP. A paper will be published by ICH early next year setting out the long-term work planning. Revision of the ICH E8 guideline “General Considerations for Clinical Trials” is mentioned as the starting point for this work next year.
Again, this is welcome news.
What we don’t know yet is whether the amendment makes it easier to do trials by taking on board our two recommendations (Solutions #1 and #2 in figure below).
The paper on the long-term plans to revise ICH-GCP and other trial guidelines sounds as if it is the first step from ICH to take on board our Solution #3, which is the need for a clear commitment from ICH to modernise other aspects of ICH-GCP.
The key point the note from ICH does not mention is whether they have taken on board our Solution #4, which is to change how we all work together to make it much easier to do trials. This requires ICH to fundamentally change by engaging in open and transparent dialogue and, in particular, to draw on the wealth of knowledge out there that knows how to do trials well. The note from Osaka says that “ICH recognises the high level of interest in GCP guidance and is committed to working with concerned stakeholders and will be seeking views as work goes forward.”
Again, sounds promising.
MoreTrials is certainly in the category of “concerned stakeholder” and our invitation now to ICH is to sit down with us early in 2017 to work out together how we take all of this work forward to make it much easier to do more and better randomised trials. An important part of this discussion will be how we can effectively bring trial participants and the public into this discussion. Sense About Science have shown how this can be done with AllTrials so we are lucky to have them as one of the driving forces behind MoreTrials. They are ready and waiting to help.
So, we wait to hear more from ICH. We will post an update here when there is more news from ICH on the amendment to ICH-GCP.
What is now clear is that ICH has a choice to either remain in the shadows defending their guideline that has caused significantly more harm than good in the 20 years since it was created or to come out in the open, engage with everybody interested in trials and work together to create something that is significantly better and whose starting point is those few key principles of how to do a randomised trial well.
2017 looks like it will be the year when we see which of these paths ICH will take.