As you can read more about here, one of the fundamental problems with the ICH-GCP guideline is that it focuses on things that don’t really matter at the expense of those few things that really do matter when conducting a randomised trial. So, let’s start out by saying in a sentence what matters when conducting a randomised trial:
Address an important question, answer that question reliably and keep participants safe.”
That’s it! You won’t find this sentence anywhere in the ICH-GCP guideline and that really matters because what you do find is a lot of other things that divert the time and attention of trialists away from this purpose.
What this single sentence does more than anything else is to make people think and ask questions, such as how can I design this study to reliably address the question? What are risks to participants and how can I effectively monitor and minimise this risk? By contrast, one of the fundamental problems with the ICH-GCP guideline and the multi-billion dollar industry that underpins it, is that it does exactly the opposite, in effect saying ‘don’t ask questions, just follow the rules.’
Further, what the ICH-GCP guideline does is to focus on a number of things that at first sight sound sensible, but are not. One example of this would be the ICH-GCP guidelines emphasis on collecting “high-quality” data, which you can read about here, along with how this flawed notion distracts from those few things that really do matter.
Given these fundamental problems with the ICH-GCP guideline, we have created MoreTrials to bring together everybody interested in randomised trials to develop a new modern set of principles of how do trials well.
You can read here how we plan to work to bring together everybody interested in trials, along with our starting point for developing the new-GCP.