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.