AllTrials campaign launches, please sign and spread!

January 16th, 2013 by Ben Goldacre in alltrials campaign, big pharma, publication bias | 2 Comments »

I am very pleased to announce the launch of a prominent campaign for access to all trial results, which we have launched this week at www.alltrials.net, with myself, Sense About Science, Sir Iain Chalmers from the James Lind Initiative (previously co-founder of Cochrane), Dr Fiona Godlee (Editor in Chief of the BMJ), and Dr Carl Heneghan (Director of the Centre for Evidence Based Medicine at Oxford).

The response so far, in a very short period of time, has been phenomenal. We have collected over 7,000 signatures already, simply from tweeting, and several extremely high profile organisations have signed up already, including:

  • The Medical Research Council
  • The Cochrane Collaboration
  • IQWiG (the German equivalent of NICE)
  • PLoS
  • BMJ Group
  • Drug and Therapeutics Bulletin

… and many more to come.

If your organisation would like to support the alltrials.net campaign, please contact us here.

Please do sign up at www.alltrials.net, and tell everyone you know.

- We are campaigning for governments, regulators and research bodies to ensure that all trial results are published, in full, so that doctors and patients can identify the most effective treatments.

- We are calling for the publication of all results, and full Clinical Study Reports, for all trials conducted – both past and future – on all treatments currently being used.

- We are calling for competent legislation and regulations, with robust penalties and incentives, to ensure that this requirement is met.

- Lastly, 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.

If you would also like to support the campaign further, please do also visit:

 

Spiel: 

Doctors and patients need the results of clinical trials to make informed decisions about which treatment is best. Unfortunately, at present, drug companies and researchers are perfectly entitled to withhold the results of clinical trials if they wish to do so. This is a problem, because it means that the evidence we see is skewed, usually in favour of a treatment.

The best currently available evidence shows that this problem is extremely common: overall, about half of all clinical trials have never been published, and we know that 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: we             need to have all the evidence about a treatment, in order to understand its true risks and benefits. If you tossed a coin 50 times, but only shared the outcome when it came up heads, 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.

The scale of this problem is enormous. It exposes patients to unnecessary harm, because the wrong treatment may be prescribed when the evidence is distorted. It also affects some very expensive drugs. For example, governments around the world have spent billions on a drug called Tamiflu: the UK alone spent £500 million on this drug in 2009, which is 5% of the total £10bn NHS drugs budget, on one drug. But Roche, the drug’s manufacturer, published fewer than half of the clinical trials conducted on it, and continue to withhold vitally important information about these trials from doctors and researchers even today. Some academics now suspect that the drug may be no better than paracetamol.

Many things have been tried to fix this problem, but they have all failed. Since 2008, for example, an FDA has required results of all trials to be posted within a year of completion. Howeber, no public audit was conducted, and an audit published in 2012 has now shown that 80% of trials failed to comply with this law. Despite this fact, no fines have ever been issued for non-compliance. Furthmore, even if this rule had been enforced, most currently used drugs came on the market before 2008, so the trial results we need to practice medicine safely still cannot be accessed.

We believe that this situation cannot be allowed to go on.

 

 

 


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2 Responses



  1. overlylongusername said,

    January 18, 2013 at 8:07 pm

    It is important to have as much data as is possible available to the public in order to help prevent researchers from misrepresenting the efficacy of treatments.

    While much emphasis has been placed upon drug trials and pharmaceutical companies, there are also serious problems with the way in which researchers promote their behavioural treatments.

    Two large and expensive publicly funded trials of behavioural interventions recently reported results recently, the related FINE and PACE trials. FINE reported it’s results first, and stuck to the outcome measures laid out in it’s published protocol. It found that the researcher’s treatments did not lead to a significant improvement for patients. By the time PACE reported it’s results, dramatic changes had been made to the way in which outcome measures were reported, what was classed as the primary outcome measures were never released, and claims about efficacy unsupported by the evidence were soon circulating.

    Some patients were unsurprisingly angered by this, but because they have become so stigmatised, particularly if they are to criticise those making money from their condition, their justified irritation is seen by some as further reason to support those researchers making false claims about the efficacy of treatments, with Freedom of Information requests for data now being presented as ‘harassment’ of researchers.

    One can google “New attempt to avoid releasing data on ‘recovery’ from PACE” to find a patient discussion, along with links to an FOI which includes links to further sources of information. Patients and doctors need to be able to access reliable data about the efficacy of treatments in order to be able to avoid quackery.

  2. lisajin3141 said,

    April 1, 2013 at 11:17 am

    Just signed it. Not sure about how useful a 17-year-old student’s signature is, since opportunities to conduct actual experiments are pretty rare for us. I agree the arguments ‘for’ it are more than reasonable, and even in a children’s game you can’t ‘forget’ to use the score of a die just because the number’s not what you want.
    In a world where there are too many lies, i think it would be really useful if doctors worked together and made a freely available list of what treatments do work (with least side effects) since Bad Science makes me wonder whether medicine for hard to measure illnesses actually heals or harms. Do you agree?

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