This paper just out in the European Heart Journal is a report of a European Society of Cardiology meeting towards the end of 2015 that was one of the catalysts for creating MoreTrials.
The news item on the paper can be read here.
The paper nicely lays out the various problems with ICH-GCP and what now needs to happen to make it much easier to do more and better randomised trials. As I said last time, we welcome the progress that ICH have made in recent months updating GCP and consulting on their future plans for major renovation of GCP and the related ICH guidelines. I’ll be submitting our response from the supporters of MoreTrials tomorrow. The deadline is this Saturday (11th March).
So, my recommendation for the weekend e.g. Saturday morning:
- Don’t check email it really can spoil your weekend!
- Grab a coffee and a comfy chair
- Read the EHJ paper
- Again, don’t check email, and instead email ICH at: email@example.com with your feedback
If you’re stuck what to say in your email to ICH, politely ask them to 1) start the new guideline development with randomised trials, covering all types of trials; and, 2) this new guideline development needs to involve everybody involved in trials and be open and transparent. That in a nutshell is what we will be saying in our response to ICH, but the more of us that say this the more likely things will change for the better.
And then enjoy the rest of your weekend (and try not to look at your email in-box!)