MoreTrials: A public campaign to make it much easier to do randomised trials
ICH have just announced their plans to modernise ICH-GCP and related trials guidelines. This is welcome news and comes on the back of the announcement at the end of last year to adopt the recommendations proposed by us to the finalised addendum to ICH-GCP (E6). The reflection paper, which calls for a “renovation” of ICH-GCP is available for comment until 11th March. [Read more…]
The European Respiratory Society (ERS) has joined MoreTrials.
The ERS has members in over 140 countries bringing together healthcare professionals, medical researchers and other experts working in respiratory medicine.
ICH adopted their update to ICH-GCP on 30th November, 2016. The updated addendum can be found here.
This is the first time it has been updated since it was first created in 1996. That’s big news, but there’s more.
The update includes MoreTrials two fixes on the draft document, first, we asked to make it clear that the new text takes priority over the original text (Solution #1 above and the highlighted text from the update shown below).
.
Second, we asked that it should cross-reference other ICH guidelines that are about the conduct of trials (Solution #2 above and highlighted text from the update shown below).
ICH have also announced long-term plans for a major overhaul of ICH-GCP and will be seeking views from all stakeholders going forward. The highlighted text from their Osaka press release is here on the right.
We need to see the details when they come out next year, but our analysis is that they’ve taken on board all four of our requests to them in Lisbon back in June.
Most people involved in trials will recognise the monumental significance of this, if you do you don’t need to read on, but, if you don’t, here’s a bit of the history which will hopefully show you why we think this might be a big deal.
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.
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.