All Trials Registered | All Results Reported - The AllTrials campaign alltrials.net/blog/the-allt...
PLEASE JOIN US IN SIGNING THE PETITION: alltrials.net
About the AllTrials campaign
“Doctors and regulators need the results of clinical trials to make informed decisions about treatments.
But companies and researchers can withhold the results of clinical trials even when asked for them. The best available evidence shows that about half of all clinical trials have never been published, and trials with negative results about a treatment are much more likely to be brushed under the carpet.
This is a serious problem for evidence based medicine because we need all the evidence about a treatment to understand its risks and benefits. If you tossed a coin 50 times, but only shared the outcome when it came up heads and you didn’t tell people how many times you had tossed it, you could make it look as if your coin always came up heads. This is very similar to the absurd situation that we permit in medicine, a situation that distorts the evidence and exposes patients to unnecessary risk that the wrong treatment may be prescribed.
It also affects some very expensive drugs. Governments around the world have spent billions on a drug called Tamiflu: the UK alone spent £500 million on this one drug in 2009, which is 5% of the total £10bn NHS drugs budget. But Roche, the drug’s manufacturer, published fewer than half of the clinical trials conducted on it, and continues to withhold important information about these trials from doctors and researchers. So we don’t know if Tamiflu is any better than paracetamol.
Initiatives have been introduced to try to fix this problem, but they have all failed. Since 2008 in the US the FDA has required results of all trials to be posted within a year of completion of the trial. However an audit published in 2012 has shown that 80% of trials failed to comply with this law . Despite this fact, no fines have ever been issued for non-compliance. In any case, since most currently used drugs came on the market before 2008, the trial results that are most important for current medical practice would not have been released even if the FDA’s law was fully enforced.
We believe that this situation cannot go on. The AllTrials initiative is campaigning for the publication of the results (that is, full clinical study reports) from all clinical trials – past, present and future – on all treatments currently being used.
We are calling on governments, regulators and research bodies to implement measure to achieve this.
And we are calling for all universities, ethics committees and medical bodies to enact a change of culture, recognise that underreporting of trials is misconduct and police their own members to ensure compliance.”
SIGN NOW: alltrials.net
LATEST DEVELOPMENTS IN THE NEWS alltrials.net
EFPIA and PhRMA publish principles on clinical trial data sharing - alltrials.net/2013/efpia-an...
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Pharma companies must distance themselves from their trade bodies’ leaked strategy - alltrials.net/2013/pharmace...
Pharmaceutical company responses to leaked trade body strategy - alltrials.net/2013/pharma-r...
JOIN THE CAMPAIGN SIGN THE PETITION AND WHY THIS IS IMPORTANT - alltrials.net/blog/
“Around half of all clinical trials have not been published; some trials have not even been registered. If action is not taken urgently, information on what was done and what was found in trials could be lost forever, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated unnecessarily.
We are on the threshold of significant change, but we now urgently need help from all of you to make this a reality.
The support of 40,000 people so far has already persuaded hundreds of organisations alltrials.net/supporters/ to commit to the aim of getting all clinical trials registered and their results reported. These include regulators and faculties. GSK, one of the biggest drug companies in the world, has signed up and others are considering it. Some of these groups are now starting discussions about the practical ways to stop trial results being withheld.
So far we’ve created a ripple, and got some important commitments. We have empowered individuals in large organisations to speak up, and it has changed the mainstream opposition on this issue. In doing so, we have also challenged those who try to pretend that the problem doesn’t exist, or who falsely claim that it has already been fixed.
But this impetus for change could now go either way. Sir Iain Chalmers – co-founder of the Cochrane Collaboration – described on the MRC website insight.mrc.ac.uk/2013/04/0... how transparency has been mired in 25 years of false promises and failed initiatives. There are many who hope that AllTrials will fizzle out, and go away, as previous efforts have done. What happens next is up to all of us.
We need your help to grow internationally, and to push for a decisive and permanent change. This is what we want your help to achieve:
• One million signatures on the petition at alltrials.net. That number cannot be ignored. Ask 10 people you know to sign this week, put a link on your blog or your organisation’s website. With every 10,000 new signatures, we will send the petition to health ministers in every country and to regulators.
• More international organisations signed up. It is vitally important that organisations take a stand on this issue and join the discussion about how to get all clinical trial results reported for all treatments in current use, not just those that may come along in the future. Some of you have already been very successful in persuading professional bodies, employers and other organisations to join. Can you write to medical organisations in your country?"
More information on the AllTrials campaign alltrials.net/blog/the-allt...
This is an 8 page briefing note on missing trials, prepared by Dr Ben Goldacre with Dr Carl Heneghan (CEBM), Dr Fiona Godlee (BMJ), and Sir Iain Chalmers (JLI): Missing trials briefing note alltrials.net/wp-content/up...
Professor Peter Gøtzsche of the Nordic Cochrane Centre wrote in the BMJ on Deficiencies in proposed new EU regulation of clinical trials. bmj.com/content/345/bmj.e8522