Moretrials: the public campaign for more, better, randomised trials
Randomised trials are the most reliable way to assess the safety and effectiveness of treatments.
Decisions about our health should, wherever possible, be based upon evidence from well conducted trials.
We need more trials, and better trials in medicine.
The main obstacle to this is not what you might think it is.
It’s not the need for more money to do trials.
It’s not that people are unwilling to take part in a trial.
No, it’s the rules, the regulations that govern how trials are run.
The main problem is something called ICH-GCP, which you can read about below.
These rules rather ironically are put there in the name of “protecting patients”, but have exactly the opposite effect.
All of this means that many trials that should get done don’t and most trials that do get done are unreliable.
One disastrous result of this is to use quicker and cheaper non-randomised alternatives, such as so called "real-world data."
One leading commentator has concluded that about half of clinical research is a waste of time.
When doing a randomised trial there are only a few key things that if you get them right guarantee the value of the experiment.
Unfortunately, the regulations overlook these few key scientific principles at the expense of things that don’t really matter.
Why might this be so?
The reason is that the people who really know how to do trials well weren't involved.
These trialists for many years have repeatedly called for discussion about how we can change this, but we have been ignored.
It would be like creating rules for how to put out a fire and forgetting to ask firefighters what they think.
MoreTrials was created on 1 January 2016 in response to being ignored.
And in less than a year, on 30th November, 2016 to be precise everything began to change.
The rulemakers started to listen. The rules got updated, they got better.
This is just the start to make it much easier to do more and better trials in medicine.
Scroll down for more information........
The main regulation for trials is called ICH-GCP.
ICH is the International Council on Harmonisation and GCP is Good Clinical Practice.
It was created 20 years ago by a few drug regulators and industry.
The problem we face though is twofold.
The main problem is that ICH-GCP focuses on things that don't really matter at the expense of those few things that do matter when doing a trial.
The other problem is ICH itself. It has ignored calls for change and is closed and secretive.
You might be asking are things really that bad?
Read our letter to the European Medicines Agency (EMA) and ICH that started the MoreTrials campaign.
The solution is also 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
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.
Sense About Science are the driving force behind AllTrials, which has changed medicine for the better in just the last few years.
We look up to AllTrials as the "big sister" of MoreTrials.
We want MoreTrials to do for "doing trials" what AllTrials has done for "making trial results public."
MoreTrials now has the support of more than 200 trialists from around 30 countries
along with a number of leading research organisations who have also joined us.