Welcome to the Italian Network of Ethics Committees, Researchers and Citizens, RICERC@ who have joined the MoreTrials campaign to make it much easier to do better randomised trials.
An article from Marina Ferri on the RICERC@ website with the fantastic – wish I’d thought of that – title, “Less (GCP) is More (Trials)” points out the various problems with ICH-GCP, which have not been addressed in the recent update proposed by ICH.
Our letter pointing out these problems and what needs to be done to fix them will be considered by the ICH working group, whose membership we are not allowed to know (why, we don’t have a clue?), when it meets next in Lisbon in June. ICH then plans to finalise the update to GCP at its next meeting in Osaka in November.
Turning to the EMA, we’ve still not heard anything back from them, which is kind of ironic, given that they’ve recently announced a consultation on how they better collaborate with the academic community.Their briefing says that the EMA wants to “channel Academia’s advanced knowledge into the regulatory environment”, which I think in everyday language means, that experts in universities know a thing or two about developing drugs, so it might be sensible to listen to what they have to say.
Again, kind of ironic.