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 […]
What is MoreTrials?
MoreTrials is a public campaign started in 2016 to make it much easier to do randomised trials in medicine. It is supported by more than 260 researchers from over 35 countries and a number of leading research organisations, including the European Society of Cardiology and the EORTC.
What’s the problem?
Decisions about our health should, wherever possible, be based upon reliable evidence from randomised trials. Unfortunately, more often than not randomised trials don’t get done, trials don’t get completed or trials get completed but produce results that are unreliable.
What’s the cause of the problem?
Over the last 25 years randomised trials have become increasingly more complicated and difficult to do. One outcome has been an exponential rise in the cost of doing trials. This is the result of excessive and inappropriate regulation and governance of trials. Specifically, one regulation has been the main cause of the problems and it is called the ICH guideline on Good Clinical Practice (ICH-GCP).
It is no coincidence that ICH-GCP was first introduced around 25 years ago.
Who are ICH?
ICH is the International Council on Harmonisation and its membership is limited to drug regulators and the pharmaceutical industry. Other groups with expertise at doings trials, such as patient groups and researchers from universities, are not able to join ICH as members and ICH have repeatedly ignored our calls for change.
What’s the solution?
The solution is simple and obvious: Bring together all of the available expertise in an open and transparent way to develop a new guideline on how to do a randomised trial well.
Is MoreTrials having an impact?
Yes, two major funders, the Wellcome Trust and the Gates Foundation, have recently launched an initiative to develop this new guideline to replace ICH-GCP. We will work closely with them to ensure the new guideline focuses on the key principles to do a randomised trial well.
How can I help?
We welcome everybody interested in trials, including patients and patient groups, industry, professional medical societies, regulators and funders. As a member of MoreTrials you will receive regular emails with news and seeking your input on developing the new guideline to replace ICH-GCP.
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News
Major funders establish initiative to develop new trial guidelines
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 […]