Maybe, read on…………
The MoreTrials campaign has one goal to replace ICH-GCP with a modern set of principles of how to do trials well and which is developed by involving everybody in the trial community.
Contrast this with where we are now and the reason for starting this campaign at the beginning of this year.
ICH-GCP is widely agreed to fundamentally flawed by focusing on things that matter very little and largely overlooking those few key principles needed to do a trial well. If you are anything like me, it’s like having one of those days where you have one really important thing to do and end up spending all day responding to emails instead.
ICH-GCP was developed 20 years ago by just regulators and industry getting together to create ICH and repeated calls by trialists and others, who are not part of ICH, have been ignored. In short, we have a twofold problem here, the ICH-GCP guideline and ICH itself.
The recent proposed update last year to ICH-GCP, while welcome, was frankly too little too late and this is what we said in our letter of feedback to ICH and the EMA. Our expectation based on past experience was that this would be largely ignored.
Therefore, we were both surprised and pleased recently when ICH responded to our letter to inform us of the recent changes to ICH, which resulted in their name change from International Conference on Harmonisation to International Council on Harmonisation and in which they said that going forward that could now interact with a wider group of stakeholders. That was a good sign, getting a response was an event, but what happened next surprised us and, I think, will you.
On Monday, a delegation of us from the MoreTrials campaign at the invitation of the EMA attended the ICH meeting in Lisbon, Portugal.
We met for a couple of hours with the members of the ICH management committee and the working group responsible for the update to ICH-GCP. Their invitation was to hear and discuss the concerns we raised in our letter. I believe this is a first, possibly an important step in getting the change in regulation of trials that is so long overdue. You might cynically be thinking the invitation to meet us was just what they had to seen to be doing, but I genuinely think this might be the beginning of something new, something that brings together everybody involved in trials to develop appropriate and better regulation for randomised trials.
Time will tell of course. We await a formal response from ICH following our meeting with them on Monday, which we will share here when we have it. Maybe then in the next few years ICH might change their name again, this time from International Council on Harmonisation to International Collaboration on Harmonisation, when all of us, all trialists, patients and the public, everybody have a seat at the ICH table.
If this happens, we will happily amend this campaign from the current one to replace ICH-GCP to a new one, which is to update ICH-GCP.
Maybe the door to ICH is beginning to open, maybe not, maybe this is the beginning of real change. As my colleague PJ Devereaux, who flew all the way over from Canada to attend the meeting in Lisbon, said after the meeting;
“If we can get them to meet us by 100+ of us coming together, imagine what we could do if 1,000+ of us joined MoreTrials?”
So, help us by joining the campaign by subscribing by email using the box on the left.