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.
Treatment decisions should be based upon reliable evidence from randomised trials. To achieve this all trials are first registered and then the results are reported. This has been the main focus of EbM in recent years. Much progress has been made on prospective registration. The case has been made for making the results available at the end of a trial, but much more work is still required to make this work in practice. Any solution needs to be considered in terms of its impact on the whole trial ecosystem, rather than whether it just promotes some vague concept like “data sharing.”