What is MoreTrials?
MoreTrials is a public campaign started in 2016 for more and better randomised trials in medicine.
It is supported by over 230 trialists and health researchers from around 35 countries as well as a number of leading research organisations.
What is the problem?
Decisions about our health should, wherever possible, be based upon evidence from well conducted randomised trials. Over the last 20 years or so it has become much more difficult and costly to do trials.
This means that many trials that should get done don’t, many trials that get started don’t get completed and too many trials that do get done produce unreliable results.
What is the cause of the problem?
It is no coincidence that just over 20 years ago a new regulation was introduced to govern the conduct of trials.
This regulation is called the International Council on Harmonisation guideline on Good Clinical Practice, ICH-GCP for short. ICH is an international body of drug regulators and the pharmaceutical industry.
What is the problem with ICH-GCP?
Only two things really matter when doing a trial, first, keep participants safe and, second, ensure the results are reliable.
A few key scientific principles of how to do randomised trials well ensure these, but the ICH-GCP guideline does not include them and instead focuses on things, like excessive data checking and form filling, that are not really important.
How could this have happened? The reason is that the trialists who really know how to do trials well weren’t involved in writing the ICH-GCP guideline and their repeated calls for improvement were ignored by ICH.
What is the solution?
The solution is simple; develop a new guideline to update or replace ICH-GCP that is based upon the key scientific principles of how to do a randomised trial well and develop it in an open and transparent way that involves everybody in the trial community. This will include experts in doing trials, regulators, industry, other funders and also patients and the public.
Is MoreTrials having an impact?
Yes, in the last year or so ICH have for the first time started talking to experts at doing trials and have even publicly acknowledged our concerns. Their recent update to ICH-GCP whilst not addressing the fundamental problems at least included some of our suggested improvements.
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The Problem
Read our letter to the European Medicines Agency (EMA) and ICH that started the MoreTrials campaign.
the solution
The solution is twofold. First, develop a new set of guidelines for running clinical trials that focuses on those few things that really matter.
And second, develop it in an open and transparent way that involve everybody who wants to be involved.
Writing the new-GCP
How we plan to work
Highlighting the Fundamental Problems with ICH-GCP
What errors matter when doing a randomised trial?
The Heart Protection Study: Data verification – focusing on things that don’t really matter
About MoreTrials
MoreTrials was created by a number of trialists from leading universities around the world in partnership with:
The James Lind Library, an online library showing the development of fair tests of treatment.
Sir Iain Chalmers is behind that.
Sense About Science, a small campaigning charity that helps people to make sense of scientific and medical claims.
They are the driving force behind the AllTrials campaign, which has changed medicine for the better in just the last few years.
We look up to AllTrials as the "big sister" of MoreTrials and we want MoreTrials to do for "doing trials" what AllTrials has done for "making trial results public."