ICH are meeting in Osaka this week. On the agenda is the recommendation to adopt the proposed update to ICH-GCP which was published in June 2015. We welcome this update.
We only started the MoreTrials campaign this year and now with the support of over 200 trialists and a number of key research organisations we are already starting to see an impact. We’ve always been clear that we have two related problems to fix; the ICH-GCP guideline and ICH itself. The impact of the campaign is that ICH are for the first time listening to the main group that knows how to do trials well, trialists and, in fact, are now listening for the first time to any group beyond just regulators and industry.
The clearest sign of this change was when a delegation of five of us from MoreTrials were invited by the EMA and ICH to the last ICH meeting in Lisbon back in June. In Lisbon we presented to ICH the main problems that remain in the draft updated addendum and how ICH can fix them. These are the four problems and the solutions:
The first two problems (#1/#2) can be quickly fixed by ICH in Osaka this week so we wait to see what they decide to do. This is progress, a start of maybe something good, but the fix is only a “sticking plaster.”
But what we also need to see is from Osaka is a clear commitment from ICH that things have changed in a fundamental way. This will begin a collaborative process involving everybody involved in trials to make it much easier to do better trials. This is what #3/#4 are about. When we say ‘everybody’ that, of course, includes patients and the public, another group that ICH have ignored and excluded for more than 20 years. I don’t think there is a credible defence against that one.
While the signs are good, ICH is a strange beast. You won’t find any report or record of the discussion with MoreTrials at the last Lisbon meeting. They also wouldn’t tell us who were the 30+ people who were at the meeting with us. That still seems a bit odd.
So, what next?
For MoreTrials, much of the same. If you haven’t already done so, join us, if you have, thank you and spread the word by telling your contacts that MoreTrials in a short time is having a real impact and they too should now join.
What will be new over the coming months are two things. First, we will as a community start to write a New-GCP to replace ICH-GCP, or maybe, but it’s too early to say at the moment, to update ICH-GCP.
The second thing we need to do is to make MoreTrials a public campaign. Whatever ICH decide to do or not we will be moving forward on the public campaign.
Whether it is to replace ICH-GCP or work with ICH and everybody else involved in trials to update ICH-GCP largely depends upon what ICH decide to do in Osaka this week.