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.
What you should do if you think the ICH-GCP guideline is really GOOD?
We’re not going to have a cheap shot and say “see your doctor”, no, we really want to hear from you!
Most websites are like digital-brochures, in that it is impossible or really difficult to share comments, have a dialogue, be heard (we’ve spent many a night shouting at the ICH website, but what good does that do). MoreTrials is different, in that it is very deliberately built on a digital media platform (a fancy name for a modern website) that promotes interaction, so if you think the ICH-GCP guideline is really good and we are WRONG and we don’t need to replace it with the new-GCP then let us know by contacting us here.
Look, everybody we talk to says the ICH-GCP guideline is really bad, but maybe we’re not talking to the right people, so if you think it is really good, tell us.
You probably won’t have seen this done before, but over on the left we’ve created a page called “Have your say”. From what you’ve read so far, we clearly don’t have much (anything?) good to say about either the ICH-GCP guideline or ICH itself, but we want to invite anybody who thinks that the guideline is good, that ICH are doing a great job to post their comments on this page.
If you think the recent update to the ICH-GCP guideline is really terrific, tell us by posting a comment here.
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.