How might this work? And, yes, it might NOT work!
We very deliberately don’t have a specific plan for how this might work and, yes, of course, it might NOT work, but it’s much better than moaning about the ICH-GCP guideline without doing anything to improve things. We’ve tried talking to ICH, but they’ve largely ignored us and their recent update just shows that they are most definitely not the solution to the problem they’ve created.
Our ultimate aim though is to make it much easier to do randomised trials and to do this by developing a replacement for the ICH-GCP guideline that involves everybody interested in randomised trials.
We strongly believe that this replacement for the ICH-GCP guideline which we will call the new-GCP, should be developed in an open and transparent manner that involves everybody involved or interested in trials. That’s not so difficult now with the internet and we’ve chosen to develop this website in a way that promotes discussion and interaction. We will do this by using online forums, webinars, podcasts or anything else you’d like to suggest. For example, if you just want to keep informed of how things are moving forward then all you have to do is subscribe via email on the left of this page. We want to post a new blog around once a week to stimulate discussion and build a community of people around the world to develop the new-GCP. We also want to highlight and celebrate the unique value of randomised trials.
Are ICH excluded from the party?
No, we’d love to hear from ICH, the drug regulators and the pharmaceutical industry that support and finance them. Everybody is welcome to join the campaign. Our criticism of ICH is in no way directed at the people who work there, like most people they’re just trying to do a half-decent job. It sometimes feels to us though that ICH are holed up in a bunker in Switzerland so maybe it would be good for them to get out more.