Everybody agrees that ICH-GCP needs renovation and it has now become clear that two very different pathways are emerging to take this forward.
One of these pathways involves ICH – whose membership is limited to some of the regulators and some pharma companies – spending something like the next 18 months to 2 years behind closed doors to come up with a totally revised version of GCP and then putting a final draft out for public comment. This reality became clearer recently when ICH published the names of the members of the “expert” working group to take this forward:
I only recognise one of the names and there is no accompanying information on what trial expertise these so called “experts” bring to the table. We have repeatedly over the last four years raised the concern that all stakeholders concerned with clinical trials, but particularly academic trialists and patient groups, must be involved in the development of a new GCP (for example, our March 2017 letter setting out these concerns and which, incidentally, we never received a response from ICH).
So, looking at the membership my questions to ICH are as follows:
- What specific clinical trial expertise do the members of the “expert” working group on GCP have? What meaningful trials have they done?
- Where are the academic trialists in the membership?
- Where are the patient groups in the membership?
I will put these questions to ICH and, if we get a response, I’ll let you know.
Thankfully, there is a second pathway. This is the one recently set up by the Wellcome Trust, the Gates Foundation and African Academy of Sciences which you can learn more about here. This joint initiative sets out to develop new principle-based guidelines for running clinical trials. It is early days yet but the initial signs are really good with a commitment to develop the guidelines in an open and transparent way and the appointment of a leading trialist to lead the initiative.
So, we are in interesting times where we have a choice between the first pathway proposed by ICH where everybody in the trial community effectively buries their heads in the sand for the next 18 months to two years all the time hoping that the so called “experts” come up with something that works, something much, much better. By contrast, the second pathway sets out to develop a new guideline to replace GCP that is based upon the key principles to do a randomised trial well and which involves from the outset everybody in the trial community.
MoreTrials supporter and trialist PJ Devereaux from McMaster summed it up nicely in feedback to ICH on the original creation of ICH-GCP with the following analogy:
“Imagine creating a regulation for putting out fires and forgetting to ask firefighters for their input. Sounds absurd I know, but that’s exactly what we’ve done in regulating trials by not involving trialists”
It looks to me like we are making the same mistake again.
I know which pathway I’m going to take. If you are a trialist or a patient group it is time for you to decide which pathway you are going to take?