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:

1. What specific clinical trial expertise do the members of the “expert” working group on GCP have? What meaningful trials have they done?
2. Where are the academic trialists in the membership?
3. 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?

The Wellcome Trust, the Gates Foundation and the African Academy of Sciences have come together to form a new initiative to develop new guidelines for clinical research. They point out that ICH-GCP was developed for product registration trials and today is applied much more broadly and this has created a need for new guidelines. The funders want these new guidelines to be based upon scientific evidence, straightforward and simple, adaptable to individual studies and suitable and relevant for the multiple settings and contexts where trials are run (including low- and middle-income countries).

The initiative is currently hiring a scientific lead for the project. MoreTrials very much welcomes this new initiative and will be working closely with it over the coming months.

More information can be found here.

“Basically, if trials are going to be done there are lots and lots of questions that could be answered by trials and should be answered by trials and will not be answered by trials unless we reduce the regulatory burden on trials”

Professor Sir Richard Peto

Introducing the 2018 Archie Cochrane Lecture given by Professor Martin Landray at Green Templeton College, Oxford on 15th March, 2018.

Martin’s lecture, “Re-inventing randomised trials for the 21st century” will be featured here soon

One of the main problems with ICH-GCP is that it has made randomised trials much more complex and costly than they need to be. The result has been an ever increasing cost of doing trials with reports of single phase-3 trials now costing as much as a billion US dollars. This not only prevents the development of many potential new treatments, but makes it much more difficult to properly evaluate many existing treatments and other interventions. Therefore, there is an urgent need to reduce the cost of randomised trials.

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