AllTrials

All TrialsI’m going to publish something today which I believe is very important.

That thing is AllTrials. All trials registered. All results reported.

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 [1].

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 [2]. 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.

They recently emailed everyone who has signed up to the petition, saying this:

Dear Friend

You, and 40,000 other people around the world, have signed the AllTrials petition. We are on the threshold of significant change, but we now urgently need help from all of you to make this a reality.

Your support has already persuaded hundreds of organisations 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 – this week described on the MRC website 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. 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
  • £40,000 so we can keep going. So far we have worked with almost no budget. At EvidenceLive last week we appealed for help and immediately received £6,000 of pledges, which is so welcome. We need funds to produce a website that keeps everyone updated on the campaign, to spread news and to organise events. We need the time to work with policy makers who are being aggressively briefed by organisations spending vast sums on lobbyists. Please donate whatever you can, even very small amounts make a difference:  www.justgiving.com/alltrials, and let us know if there are other ways you can help raise funds.

If you have anything further to offer, please contact Síle Lane slane@senseaboutscience.org.

Thank you also for the material you have been sending us about the effects of secrecy and transparency. Over the coming weeks we’ll be making sure that the world hears a lot more about this issue.

Twenty five years of failure is too long. Doctors need all the results, of all the trials, on all the treatments we use today. With your help, we could now achieve this, together.

Best wishes

Ben and Tracey

For those of you who read my blog, I would love it if you could take a couple of minutes and sign up to the AllTrials campaign. If you’ve taken any sort of medicine or drug in your life, you owe it to yourself to know that that drug has been rigorously tested. This campaign can make sure of that. [Some extra data in PDF form].

Thank you. Onwards!

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One Response to AllTrials

  1. Pingback: AllTrials: Make Clinical Trials Count | Richer Ramblings

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